A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.
- Conditions
- Rheumatoid arthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2010-018375-22-BG
- 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
Adult patients >= 18 years
Rheumatoid arthritis of >= 6 months duration
Swollen joint count (SJC) = 4 (66 joint count), and tender joint count (TJC) = 4 (68 joint count) both at screening and baseline visits
At screening, CRP =10 mg/L (= 1 mg/dL) and/or ESR = 28 mm/h
Have to be on at least one permitted DMARD, which has been at a stable dose for at least 8 weeks prior to baseline
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 1043
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 219
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomisation
Prior history of or current inflammatory joint disease other than RA
Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20.
Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: • The efficacy of treatment with 162 mg tocilizumab (TCZ) given subcutaneously (SC) weekly<br>versus 8 mg/kg TCZ given intravenously (IV) every 4 weeks with regard to noninferiority of the proportion of patients who achieve ACR20 at Week 24.<br>• The safety of treatment with 162 mg TCZ given SC weekly versus 8 mg/kg TCZ<br>given IV every 4 weeks, with regard to AEs and laboratory assessments.;Secondary Objective: • Long-term safety and efficacy<br>• PK and PD of TCZ following SC 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 primary endpoint will be the proportion of patients achieving an ACR 20 response at Week 24.;Timepoint(s) of evaluation of this end point: week 24<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Proportion of patients with an ACR50 response at Week 24<br>2. Proportion of patients with an ACR70 response at Week 24<br>3. Proportion of patients with a DAS28 < 2.6 (DAS remission) at Week 24<br>4. Proportion of patients achieving a decrease of =0.3 in HAQ-DI from baseline to Week 24<br>5. Proportion of patients who withdrew due to lack of therapeutic response at Week 24<br>;Timepoint(s) of evaluation of this end point: week 24