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OpenTrials
Completed

NCT Number: NCT01443364

Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

11, Bari, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years
  • positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP)
  • active RA disease
  • subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD).
  • subject is naïve to RA related biologics

Exclusion criteria

  • a diagnosis of any other inflammatory arthritis
  • history of infected joint prosthesis, or other significant infection
  • known Tuberculosis (TB) disease or high risk of acquiring TB infection

Treatment and study plan

Certolizumab Pegol

Biological

Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.

Other names: CIMZIA, CZP

Primary outcomes

  1. The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52

    Time frame: From Baseline to Week 12 and Week 52

    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  2. The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52

    Time frame: From Baseline to Week 8 and Week 52

    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  3. The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52

    Time frame: From Baseline to Week 6 and Week 52

    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  4. The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52

    Time frame: From Baseline to Week 4 and Week 52

    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  5. The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52

    Time frame: From Baseline to Week 2 and Week 52

    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

  6. The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52

    Time frame: From Baseline to Week 1 and Week 52

    Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system

Secondary outcomes

  1. Change From Baseline in the Synovial Fluid and Proliferation at Week 52

    Time frame: From Baseline to Week 52

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  2. Change From Baseline in the Synovial Fluid and Proliferation at Week 36

    Time frame: From Baseline to Week 36

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  3. Change From Baseline in the Synovial Fluid and Proliferation at Week 24

    Time frame: From Baseline to Week 24

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  4. Change From Baseline in the Synovial Fluid and Proliferation at Week 12

    Time frame: From Baseline to Week 12

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  5. Change From Baseline in the Synovial Fluid and Proliferation at Week 8

    Time frame: From Baseline to Week 8

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  6. Change From Baseline in the Synovial Fluid and Proliferation at Week 6

    Time frame: From Baseline to Week 6

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  7. Change From Baseline in the Synovial Fluid and Proliferation at Week 4

    Time frame: From Baseline to Week 4

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  8. Change From Baseline in the Synovial Fluid and Proliferation at Week 2

    Time frame: From Baseline to Week 2

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  9. Change From Baseline in the Synovial Fluid and Proliferation at Week 1

    Time frame: From Baseline to Week 1

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  10. Change From Baseline in the Doppler Signal and Blood Flow at Week 52

    Time frame: From Baseline to Week 52

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  11. Change From Baseline in the Doppler Signal and Blood Flow at Week 36

    Time frame: From Baseline to Week 36

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  12. Change From Baseline in the Doppler Signal and Blood Flow at Week 24

    Time frame: From Baseline to Week 24

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  13. Change From Baseline in the Doppler Signal and Blood Flow at Week 12

    Time frame: From Baseline to Week 12

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  14. Change From Baseline in the Doppler Signal and Blood Flow at Week 8

    Time frame: From Baseline to Week 8

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  15. Change From Baseline in the Doppler Signal and Blood Flow at Week 6

    Time frame: From Baseline to Week 6

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  16. Change From Baseline in the Doppler Signal and Blood Flow at Week 4

    Time frame: From Baseline to Week 4

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  17. Change From Baseline in the Doppler Signal and Blood Flow at Week 2

    Time frame: From Baseline to Week 2

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  18. Change From Baseline in the Doppler Signal and Blood Flow at Week 1

    Time frame: From Baseline to Week 1

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  19. Change From Baseline in the Cartilage Damage at Week 52

    Time frame: From Baseline to Week 52

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  20. Change From Baseline in the Cartilage Damage at Week 36

    Time frame: From Baseline to Week 36

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  21. Change From Baseline in the Cartilage Damage at Week 24

    Time frame: From Baseline to Week 24

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  22. Change From Baseline in the Cartilage Damage at Week 12

    Time frame: From Baseline to Week 12

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  23. Change From Baseline in the Cartilage Damage at Week 8

    Time frame: From Baseline to Week 8

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  24. Change From Baseline in the Cartilage Damage at Week 6

    Time frame: From Baseline to Week 6

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  25. Change From Baseline in the Cartilage Damage at Week 4

    Time frame: From Baseline to Week 4

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  26. Change From Baseline in the Cartilage Damage at Week 2

    Time frame: From Baseline to Week 2

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  27. Change From Baseline in the Cartilage Damage at Week 1

    Time frame: From Baseline to Week 1

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  28. Change From Baseline in the Bone Erosion at Week 52

    Time frame: From Baseline to Week 52

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  29. Change From Baseline in the Bone Erosion at Week 36

    Time frame: From Baseline to Week 36

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  30. Change From Baseline in the Bone Erosion at Week 24

    Time frame: From Baseline to Week 24

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  31. Change From Baseline in the Bone Erosion at Week 12

    Time frame: From Baseline to Week 12

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  32. Change From Baseline in the Bone Erosion at Week 8

    Time frame: From Baseline to Week 8

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  33. Change From Baseline in the Bone Erosion at Week 6

    Time frame: From Baseline to Week 6

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  34. Change From Baseline in the Bone Erosion at Week 4

    Time frame: From Baseline to Week 4

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  35. Change From Baseline in the Bone Erosion at Week 2

    Time frame: From Baseline to Week 2

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  36. Change From Baseline in the Bone Erosion at Week 1

    Time frame: From Baseline to Week 1

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  37. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52

    Time frame: From Baseline to Week 52

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  38. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36

    Time frame: From Baseline to Week 36

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  39. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24

    Time frame: From Baseline to Week 24

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  40. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12

    Time frame: From Baseline to Week 12

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  41. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8

    Time frame: From Baseline to Week 8

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  42. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6

    Time frame: From Baseline to Week 6

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  43. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4

    Time frame: From Baseline to Week 4

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  44. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2

    Time frame: From Baseline to Week 2

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  45. Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1

    Time frame: From Baseline to Week 1

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  46. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52

    Time frame: From Baseline to Week 52

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  47. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36

    Time frame: From Baseline to Week 36

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  48. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24

    Time frame: From Baseline to Week 24

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  49. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12

    Time frame: From Baseline to Week 12

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  50. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8

    Time frame: From Baseline to Week 8

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  51. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6

    Time frame: From Baseline to Week 6

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  52. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4

    Time frame: From Baseline to Week 4

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  53. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2

    Time frame: From Baseline to Week 2

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  54. Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1

    Time frame: From Baseline to Week 1

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  55. Synovial Fluid and Proliferation at Week 52

    Time frame: Week 52

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  56. Synovial Fluid and Proliferation at Week 36

    Time frame: Week 36

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  57. Synovial Fluid and Proliferation at Week 24

    Time frame: Week 24

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  58. Synovial Fluid and Proliferation at Week 12

    Time frame: Week 12

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  59. Synovial Fluid and Proliferation at Week 8

    Time frame: Week 8

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  60. Synovial Fluid and Proliferation at Week 6

    Time frame: Week 6

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  61. Synovial Fluid and Proliferation at Week 4

    Time frame: Week 4

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  62. Synovial Fluid and Proliferation at Week 2

    Time frame: Week 2

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  63. Synovial Fluid and Proliferation at Week 1

    Time frame: Week 1

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  64. Synovial Fluid and Proliferation at Week 0

    Time frame: Week 0 (Baseline)

    The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  65. Doppler Signal and Blood Flow at Week 52

    Time frame: Week 52

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  66. Doppler Signal and Blood Flow at Week 36

    Time frame: Week 36

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  67. Doppler Signal and Blood Flow at Week 24

    Time frame: Week 24

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  68. Doppler Signal and Blood Flow at Week 12

    Time frame: Week 12

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  69. Doppler Signal and Blood Flow at Week 8

    Time frame: Week 8

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  70. Doppler Signal and Blood Flow at Week 6

    Time frame: Week 6

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  71. Doppler Signal and Blood Flow at Week 4

    Time frame: Week 4

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  72. Doppler Signal and Blood Flow at Week 2

    Time frame: Week 2

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  73. Doppler Signal and Blood Flow at Week 1

    Time frame: Week 1

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  74. Doppler Signal and Blood Flow at Week 0

    Time frame: Week 0 (Baseline)

    The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity.

  75. Cartilage Damage at Week 52

    Time frame: Week 52

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  76. Cartilage Damage at Week 36

    Time frame: Week 36

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  77. Cartilage Damage at Week 24

    Time frame: Week 24

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  78. Cartilage Damage at Week 12

    Time frame: Week 12

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  79. Cartilage Damage at Week 8

    Time frame: Week 8

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  80. Cartilage Damage at Week 6

    Time frame: Week 6

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  81. Cartilage Damage at Week 4

    Time frame: Week 4

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  82. Cartilage Damage at Week 2

    Time frame: Week 2

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  83. Cartilage Damage at Week 1

    Time frame: Week 1

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  84. Cartilage Damage at Week 0

    Time frame: Week 0 (Baseline)

    The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  85. Bone Erosion at Week 52

    Time frame: Week 52

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  86. Bone Erosion at Week 36

    Time frame: Week 36

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  87. Bone Erosion at Week 24

    Time frame: Week 24

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  88. Bone Erosion at Week 12

    Time frame: Week 12

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  89. Bone Erosion at Week 8

    Time frame: Week 8

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  90. Bone Erosion at Week 6

    Time frame: Week 6

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  91. Bone Erosion at Week 4

    Time frame: Week 4

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  92. Bone Erosion at Week 2

    Time frame: Week 2

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  93. Bone Erosion at Week 1

    Time frame: Week 1

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  94. Bone Erosion at Week 0

    Time frame: Week 0 (Baseline)

    The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity.

  95. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52

    Time frame: Week 52

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  96. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36

    Time frame: Week 36

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  97. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24

    Time frame: Week 24

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  98. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12

    Time frame: Week 12

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  99. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8

    Time frame: Week 8

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  100. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6

    Time frame: Week 6

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  101. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4

    Time frame: Week 4

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  102. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2

    Time frame: Week 2

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  103. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1

    Time frame: Week 1

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  104. Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0

    Time frame: Week 0 (Baseline)

    The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity.

  105. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52

    Time frame: Week 52

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  106. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36

    Time frame: Week 36

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  107. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24

    Time frame: Week 24

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  108. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12

    Time frame: Week 12

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  109. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8

    Time frame: Week 8

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  110. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6

    Time frame: Week 6

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  111. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4

    Time frame: Week 4

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  112. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2

    Time frame: Week 2

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  113. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1

    Time frame: Week 1

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

  114. Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0

    Time frame: Week 0 (Baseline)

    The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity.

Sponsors and collaborators

Lead sponsor

UCB Italy s.p.a.

Industry

Registry information

Official study title

Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

Acronym: SPEED

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 29, 2011
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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