Study designed to assess the short- and long-term efficacy of CZP compared with Adalimumab, both when used with methotrexate (MTX) in the treatment of subjects suffering from rheumatoid arthritis not responding adequately to MTX. Adalimumab is a recombinant human IgG1 monoclonal antibody specific for human TNF that has been approved for the treatment of moderate to severe active RA in the USA, the EU and a n. of other countries worldwide

Conditions: Moderate to severe rheumatoid arthritis
MedDRA version: 14.1Level: LLTClassification code 10003268Term: Arthritis rheumatoidSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-002067-20-IT

Lead Sponsor: CB PHARMA SA/NV.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 892

Inclusion Criteria

1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject. 2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule or medication intake according to the judgment of the Investigator. 3. Subject is >=18 years of age at Screening. 4. Subject must have a diagnosis of RA at Screening, as defined by the 2010 EULAR/ACR classification criteria (Aletaha D et al, 2010). 5. Subject must have a positive rheumatoid factor (RF) and/or a positive anti cyclic citrullinated peptide antibody (anti-CCP) at Screening. 6. Subject must have moderate to severe RA disease at Screening and Baseline as defined by: • >= 4 swollen joints (of 28 prespecified joints).• DAS28(ESR) >3.2. • CRP concentration >10mg/L (or 1.0mg/dL) and/or ESR (Westergren) >= 28mm/hr. 7. Subject must have inadequately responded previously to MTX. Methotrexate-inadequate response is defined as not having achieved DAS28(ESR) <= 3.2 during the 3 to 6 months prior to the Screening Visit according to the Investigator. 8. Subject is using MTX 15 to 25mg/week orally or subcutaneously at Baseline and has used the same MTX regimen (dose and route) during the 56 days prior to Baseline. A MTX dose at a minimum of 10mg/wk orally or subcutaneously is acceptable for subjects considered by the Investigator to be intolerant to a higher dose of MTX. 9. Subject, if using oral corticosteroids at Baseline, is receiving at a stable dose of <= 10mg (unchanged for at least 28 days prior to Baseline). 10. The subject, if female, must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence only is not an acceptable method. Subjects must agree to use adequate contraception from Screening through at least 10 weeks (or longer if required by local regulations) after the final dose of IMP. Male subjects must agree to ensure they or their female partner(s) use adequate contraception from Screening through at least 10 weeks (or longer if required by local regulations) after the final dose of IMP.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 446
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 446

Exclusion Criteria

1. Subject has previously participated in this study or has previously received any bDMARD during another clinical study or independent of another clinical study. 2. Subject has participated in another study of medication or a medical device within the previous 3 months or is currently participating in another study of a medication or medical device under investigation. 3. If a female subject, is breastfeeding, pregnant, or plans to become pregnant during the study or within 10 weeks following final dose of IMP or thereafter according to local regulations. 4. Subject has a known hypersensitivity to any components of CZP or ADA, or a history of an adverse reaction to polyethylene glycol (PEG). 5. Subject has a contraindication to the use of CZP, ADA, or MTX. 6. Subject must not have a secondary, noninflammatory type of musculoskeletal condition (eg, osteoarthritis or fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of the IMP on the subject's primary diagnosis of RA. 7. Subject must not have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis) or have a Steinbrocker IV functional capacity. 8. Subject must not have previously received any experimental nonbiological therapy. 9. Subject must be free of prohibited use or a limited use of concomitant medication as detailed in Table 6:1 of the Protocol. 10. Subject with concurrent malignancy or a history of malignancy (subjects with fewer than 3 excised basal cell carcinomas or with cervical carcinoma in situ successfully surgically treated more than 5 years prior to Screening may be included). 11. Subject with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease. 12. Subjects with a history of blood dyscrasias. 13. Subject with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease or other significant immunological/inflammatory disease including systemic lupus erythematosus or irritable bowel syndrome. 14. Subject with class III or IV congestive heart failure as defined by the New York Heart Association 1964 classification criteria. 15. Subject with a history of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis). 16. Subject with any other condition (ie, clinically significant laboratory values) which, in the judgment of the Investigator, would make the subject unsuitable for inclusion in the study. 17. Subject with a value >= 1.2xULN for any of the following liver function tests (LFTs): • Aspartate aminotransferase (AST) (glutamic oxaloacetic transaminase [GOT]). • Alanine aminotransferase (ALT) (glutamate pyruvate transaminase [GPT]). • Gamma-glutamyl transferase (GGT). 18. Subject has history of chronic alcohol or drug abuse within the previous 6 months. 19. Subject has any medical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study. 20. Subject with history of or current clinically active infection (including chest x-ray) with Histoplasma, Coccidioides, Paracoccidioides, Pneumocystis, Mycobacteria (other than tuberculosis), Blastomyces, or Aspergillus. 21. Subject with a history of c