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Completed

NCT Number: NCT02402686

Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)

The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.

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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

Observational

Primary location

Budai Irgalmasrendi Kórház KHT. II. Reumatológia, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Moderate to severe RA according to 2010 American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) joint criteria
  • Treatment with tocilizumab SC monotherapy for up to 8 weeks prior to enrollment, under the prescriptive authority of a physician who has made the decision to commence tocilizumab in accordance with the local label
  • Methotrexate intolerance, or inadequate response to prior DMARDs and TNF inhibitors where continued methotrexate treatment was deemed inappropriate

Exclusion criteria

  • Treatment with tocilizumab more than 8 weeks prior to enrollment
  • Failure to meet local tocilizumab label indication criteria
  • Treatment with any investigational agent within 4 weeks of beginning tocilizumab SC monotherapy
  • Last methotrexate dose within 1 week of beginning tocilizumab SC monotherapy
  • History of any other autoimmune or joint inflammatory disease

Treatment and study plan

Tocilizumab

Drug

Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.

Other names: RoActemra

Primary outcomes

  1. Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study

    Time frame: Baseline, end of study (up to 24 weeks)

Secondary outcomes

  1. Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study

    Time frame: Baseline, end of study (up to 24 weeks)

  2. Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6

    Time frame: Up to 24 weeks

  3. Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8

    Time frame: Up to 24 weeks

  4. Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups

    Time frame: Baseline, end of study (up to 24 weeks)

    The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.

  5. Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6

    Time frame: Up to 24 weeks

    The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.

  6. Number of Tocilizumab SC Injections per Participant During Observational Treatment Period

    Time frame: Up to 24 weeks

  7. Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations

    Time frame: Up to 24 weeks

  8. Percentage of Participants on SC Tocilizumab First Line Monotherapy

    Time frame: Up to 24 weeks

  9. Percentage of Participants with Reasons for SC Tocilizumab Monotherapy

    Time frame: Up to 24 weeks

  10. Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week)

    Time frame: Up to 24 weeks

  11. Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period

    Time frame: Baseline, Week 24

  12. Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study

    Time frame: Baseline, Week 24

  13. Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period

    Time frame: Week 24

  14. Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission

    Time frame: Up to 24 weeks

    The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.

  15. Percentage of Participants with Adverse Events

    Time frame: Up to 24 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)

Acronym: SIMPACT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 30, 2015
Registry last updated
Dec 6, 2019

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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