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Completed

NCT Number: NCT01163747

A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)

This randomized, parallel-group, open-label study will evaluate the effect of Actemra (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an inadequate response to methotrexate and who have had an inadequate clinical response or were intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.

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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–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anniston, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, ≥ 18 to < 65 years of age
  • Rheumatoid Arthritis (RA) of > 6 months duration at baseline (American College of Rheumatology criteria)
  • Willing to receive immunization with pneumococcal polysaccharide and tetanus toxoid adsorbed vaccines
  • Previous immunization with pneumococcal polysaccharide must have occurred ≥ 3 years of baseline, with tetanus containing vaccine ≥ 5 years
  • Methotrexate therapy for at least 8 weeks prior to baseline at stable dose of 7.5-25 mg/week (oral or parenteral)
  • Other disease-modifying antirheumatic drugs (DMARDs) must be withdrawn before baseline
  • Oral corticosteroids must be at stable dose of < 10 mg/day prednisone or equivalent
  • Body weight ≤ 150 kg at screening

Exclusion criteria

  • Major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 8 weeks after baseline
  • History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA
  • Pre-existing central nervous system demyelinating or seizure disorders
  • Active current or history of recurrent bacterial, viral fungal, mycobacterial and other infections
  • Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks prior to baseline or oral antibiotics within 2 weeks prior to baseline
  • Active tuberculosis requiring treatment within 3 years prior to baseline
  • Primary or secondary immunodeficiency (history or currently active)
  • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
  • Previous treatment with RoActemra/Actemra

Treatment and study plan

Tocilizumab

Biological

Intravenous repeating dose

Other names: RoActemra, Actemra

methotrexate

Drug

A stable dose of between 7.5 and 25 mg/week, oral or parenteral.

23-valent pneumococcal polysaccharide vaccine

Biological

Intramuscular or subcutaneous injection

Other names: Pneumovax

Tetanus Toxoid Adsorbed Vaccine

Biological

Intramuscular injection

Primary outcomes

  1. Percentage of Participants Who Responded to ≥ 6 of 12 Anti-pneumococcal Antibody Serotypes

    Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

    Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.

    The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.

Secondary outcomes

  1. Percentage of Participants Who Responded to Combinations of 12 Anti-Pneumococcal Antibody Serotypes

    Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

    Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.

    The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 8, 9N, 12F, 14, 19F, 23F, 7F, and 18C.

  2. Percentage of Participants With a Positive Response to Tetanus Toxoid Vaccination

    Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

    A positive response to the tetanus toxoid vaccination was defined as antibody levels ≥ 0.2 IU/mL for participants with Baseline tetanus antibody levels < 0.1 IU/mL, or a 4-fold increase in antibody levels compared with Baseline for participants with Baseline tetanus antibody levels ≥ 0.1 IU/mL.

  3. Change From Baseline in Levels of Anti-pneumococcal Antibody 5 Weeks After Vaccination

    Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

    Levels of anti-pneumococcal antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).

  4. Change From Baseline in Levels of Anti-tetanus Antibody 5 Weeks After Vaccination

    Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

    Levels of anti-tetanus antibodies were measured by a central laboratory from serum samples taken prior to vaccination (Week 3) and 5 weeks post vaccination (Week 8).

  5. Percentage of Participants Who Responded to Each of the 12 Anti-Pneumococcal Antibody Serotypes

    Time frame: Baseline (Week 3) and Week 8 (5 weeks post-vaccination)

    Serum levels of antibody to pneumococcal vaccine were drawn 5 weeks after vaccination with 23-valent pneumococcal polysaccharide vaccine to assess humoral immune response. A positive response to the pneumococcal vaccine was defined as a 2-fold increase in serum antibody titers from Baseline or an increase of > 1 mg/L from Baseline levels.

    The 12 serotypes evaluated were pneumococcal serotypes 1, 3, 4, 6B, 7F, 8, 9N, 12F, 14, 18C, 19F and 23F.

  6. Number of Participants With Adverse Events Through Week 8

    Time frame: 8 weeks

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any AE that is fatal or is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 16, 2010
Registry last updated
Dec 7, 2012

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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