NL-OMON33758CompletedPhase 3
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. - C87094 / REALISTIC
CB Pharma0 sites60 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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