A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.
- Conditions
- RArheumatoid arthritis1000381610023213
- Registration Number
- NL-OMON36590
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
1) Able and willing to give written informed consent
2) Rheumatoid arthritis of at least 6 months duration diagnosed according to the ACR criteria
3) Age 18 years or older
4) Have experienced an inadequate response due to inefficacy of treatment with only one approved anti-TNF agent other than adalimumab
5) Have received MTX for at least 12 weeks immediately prior to baseline
6) DAS28 score at baseline greater than 3.2
7) Females of child-bearing potential may participate in this trial only if using reliable means of contraception
8)Receiving treatment on an outpatient basis
1) Major surgery within 8 weeks prior to screening or planned surgery within 6 months following randomization
2) Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissuedisease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty's syndrome)
3) Functional class IV as defined by the ACR criteria for Classification of Functional Status in Rheumatoid Arthritis
4) Prior history of current inflammatory joint disease other than RA
5) History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies including tocilizumab
6) Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease
7) Uncontrolled disease status, such as asthma, psoriasis or inflammatory bowel disease
8) Active TB requiring treatment within the previous 3 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the efficacy of treatment with tocilizumab versus adalimumab, both in<br /><br>combination with methotrexate, with regard to achievement of clinical remission<br /><br>as measured by DAS28 at the end of week 24 in patients with moderate to severe<br /><br>RA who have had an inadequate response to treatment with only one TNF<br /><br>inhibitor.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Investigating additional effects of tocilizumab and adalimumab by assessing:<br /><br><br /><br>* Efficacy parameters at week 24 by using ACR and EULAR criteria, low disease<br /><br>activity scores, questionnaires to measure daily activities, fatigue,<br /><br>depression and quality of life<br /><br>* Change of haemoglobin levels at week 24 vs baseline<br /><br>* Safety throughout the study<br /><br><br /><br>Investigating additional effects of tocilizumab and adalimumab by assessing:<br /><br><br /><br>* Proportion of patients achieving remission at week 24 according to ACR/EULAR<br /><br>criteria<br /><br>* Proportion of patients achieving remission at week 24 as defined by CDAI<br /><br>* Change of depression assessed by using Back Depression Inventory (BDI) at 24<br /><br>weeks</p><br>