A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND
- Conditions
- Rheumatoid arthritisMedDRA version: 12.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2010-018375-22-IT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
Able and willing to give written informed consent and comply with the requirements
of the study protocol (e.g. willing to take oral folate at a minimum dose of 5 mg/week
if on MTX treatment.)
2. Age ?????? 18 years
3. Rheumatoid arthritis of ?????? 6 months duration, diagnosed according to the revised 1987
American College of Rheumatology (ACR; formerly American Rheumatism
Association) criteria, Appendix 2)
4. Receive treatment on an outpatient basis.
5. Swollen joint count (SJC) ?????? 4 (66 joint count) and tender joint count (TJC) ?????? 4 (68
joint count) at screening and baseline.
6. Prior to randomization, will have discontinued etanercept for ?????? 2 weeks, infliximab,
certolizumab, golimumab, abatacept or adalimumab for ?????? 8 weeks, anakinra for ?????? 1
week.
7. Have received permitted DMARDs at a stable dose for at least 8 weeks prior to
baseline.
8. At screening CRP ?????? ULN (central laboratory).
9. Oral corticosteroids (?????? 10 mg/day prednisone or equivalent) and NSAIDs (up to the
maximum recommended dose) are permitted if on a stable dose regimen for ?????? 4
weeks prior to baseline.
10. Females of childbearing potential and males with female partners of childbearing
potential may participate in this trial only if using a reliable means of contraception
(e.g. physical barrier (patient or partner), contraceptive pill or patch, spermicide and
barrier, or IUD).
11. If female of childbearing potential, the patient must have a negative pregnancy test at
screening and baseline visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization.
2. Rheumatic autoimmune disease other than RA, including SLE, MCTD, scleroderma,
polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis,
pulmonary fibrosis or Felty’s syndrome). Secondary Sj?gren’s syndrome with RA is
allowable.
3. Functional class IV as defined by the ACR Classification of Functional Status in
Rheumatoid Arthritis (Appendix 3).
4. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA)
and/or RA before the age of 16.
5. Prior history of or current inflammatory joint disease other than RA (e.g., gout, Lyme
disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic
arthritis, arthropathy of inflammatory bowel disease).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess:<br>- The efficacy of treatment with 162 mg TCZ given subcutaneously (SC)<br>weekly versus 8 mg/kg TCZ given intravenously (IV) every 4 weeks with<br>regard to non-inferiority of the proportion of patients who achieve ACR20<br>at Week 24.<br>- The safety of treatment with 162 mg TCZ given SC weekly versus 8<br>mg/kg TCZ given IV every 4 weeks, with regard to AEs and laboratory<br>assessments.;Secondary Objective: - Long-term safety and efficacy<br>- Pharmacokinetics (PK) and pharmacodynamics (PD) of TCZ following SC<br>administration<br>- Immunogenicity of TCZ following SC administration<br>- Effect of IV to SC switch on the safety, efficacy, PK and PD of TCZ;Primary end point(s): The proportion of patients achieving an ACR 20 at Week 24.
- Secondary Outcome Measures
Name Time Method