A Phase IIIB, multicenter study with a 12-week double-blind, placebo-controlled, randomized period followed by an open-label, extension phase to evaluate the safety and efficacy of certolizumab pegol administered to patients with active rheumatoid arthritis.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

1. Patients must have a diagnosis of adult-onset RA of at least three months duration as defined by the 1987 American College of Rheumatology classification criteria.
2. Patients must have active RA disease as defined by:
• >=5 tender joints (28 joint count) at Screening and Baseline; and
• >=4 swollen joints (28 joint count) at Screening and Baseline; and
• >=10 mg/L CRP and/or >=28mm/hour ESR (Westergren) at screening.
3. Patients must have had an unsatisfactory response or intolerance to at least one traditional DMARD.

Exclusion Criteria

1. Patients must not have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
2. Patients must not have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity.
3. Patients must not have a secondary, non-inflammatory type of arthritis (e.g. osteoarthritis or fibromyalgia) that in the Investigator*s opinion is symptomatic enough to interfere with evaluation of the effect of study drug on the patient*s primary diagnosis of RA.
4. Patients must not have a history of an infected joint prosthesis at any time with that prosthesis still in situ.
5. Patients must not have received any biological therapy for RA within two months prior to Baseline visit, except for etanercept or anakinra for which a one month washout prior to baseline visit is acceptable.
6. Patients having discontinued or discontinuing biological therapy for their RA must not have had a severe hypersensitivity reaction or an anaphylactic reaction to more than 1 different biologic agent.
7. Patients must not have received treatment with more than 2 anti-TNF agents prior to enrollment in this trial.
8. Patients must not have received treatment with rituximab and/or abatacept.
9. Patients with a history of chronic infection (more than 4 episodes requiring antibiotics/antivirals during the preceding year), recent serious or life-threatening infection within 6 months (including herpes zoster), or any current sign or symptom that may indicate an infection.
10. Patients with active TB (or history of active TB), positive chest X-ray for TB, or positive PPD skin test or patients having close contact with an individual with active TB. Patients having a PPD skin test >= 5 mm can enter the study, provided that active TB is excluded and provided that they are adequately treated for latent TB and provided that treatment is initiated at least 1 month prior to first administration of CZP.
11. Patients at a high risk of infection (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections and patients who are permanently bedridden or wheelchair bound).
12. Patients with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease.
13. Patients with known concurrent acute or chronic viral hepatitis B or C.
14. Patients with known human immunodeficiency virus (HIV) infection.
15. Patients receiving any vaccination (live or attenuated) within eight weeks prior to baseline (e.g., parenteral influenza and pneumococcal vaccines are allowed, but nasal influenza vaccine is not).
16. Concurrent malignancy or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than five years prior to screening).
17. Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease.
18. Patients with class III or IV congestive heart failure according to the New York Heart Association (NYHA) 1964 classification criteria.
19. Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
20. Patients with a history of an adverse reaction to PEG.
21. Patients must not have a change in dose regiment for NSAIDs/COX-2 inhibi

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy variable is the ACR 20% (American College of Rheumatology<br /><br>20% response criteria) responder rate at Week 12.</p><br>

Secondary Outcome Measures

Name	Time	Method

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