Status:
UNKNOWN
Cimzia Treatment in Rheumatoid Arthritis: Randomizing to Stop Versus Continue Disease-modifying Anti-rheumatic Drug(s)
Lead Sponsor:
Pope Research Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate the safety and efficacy of Cimzia given as an add-on to your current therapy with disease-modifying anti-rheumatic drug(s) (DMARDs)including MTX or given as...
Detailed Description
Rheumatoid arthritis is a chronic systemic inflammatory disease that is associated with significant morbidity and mortality. The disease is characterized by inflammation of synovial joints that can re...
Eligibility Criteria
Inclusion
- Patient must be ≥ 18 years of age.
- Patient must be able to understand the information provided to them and to give written Informed Consent.
- Patient must fulfill the old or new criteria for RA (see Appendix 1) or have a clinical diagnosis of RA.
- Patient must be receiving (for 3 months before baseline) one of the following: methotrexate (≥ 12.5 mg) or another DMARD (leflunomide 10 to 20 mg/day, sulfasalazine \>1000 mg/day, IM myochrysine for at least 20 weeks at 25 mg per month or more, azathioprine\> 75mg/day), or combination DMARDs such as methotrexate with any other DMARD, or other combinations.
- If patient is on prednisone they must be on a stable dose (≤ 10 mg/day) for 1 month prior to baseline.
- Patient with active RA (≥ 3 SJC, on 28 joint count) who needs anti-TNF therapy as determined by the investigator and ability to obtain coverage for anti-TNF (Cimzia).
- Patient must not have previously been exposed to Cimzia, however, previous anti-TNF exposure is allowed.
- Patient with past anti-TNF exposure will be included if 1st anti-TNF was stopped due to secondary loss of efficacy, side effect or discontinuation for other reasons.
- Patient must use Cimzia as per the dosing guidelines in the approved product monograph.
Exclusion
- Female patient who is breast-feeding or pregnant or does plan to become pregnant over the next year
- Failure to use acceptable form of contraception in a pre-menopausal woman
- Patient with concurrent serious liver disease
- Patient with concurrent serious renal disease
- Patient with significant hematological impairments
- Patient with a history of cancer within the last 2 years, other than a successfully treated skin basal cell or squamous cell carcinoma and/or localized carcinoma in situ of the cervix
- Patient with a history of malignant lymphoma of leukemia
- Patient with a history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. Multiple Sclerosis)
- Patient with a history of untreated active tuberculosis
- Patient with positive PPD (\>5 mm) who have not had prophylaxis
- Patient with a known positive HIV test
- Patient with a persistent or severe infection(s) requiring hospitalization or treatment with iv antibiotics within 30 days or oral antibiotics within 7 days prior to baseline.
- Patient with significant congestive heart failure
- Patient with clinically significant concurrent medical of psychiatric disorders that in the physician's judgment may influence the study outcomes.
- Patient with any condition that would prevent participation or completion in this study including language limitation or possibility that the patient will not be available for the complete study period
- Patient with severe noncompliance
- Patient receiving an experimental product within the last 6 weeks prior to first dose of Cimzia.
- Other joint disease or joint pain condition where the patient or physician cannot distinguish RA assessments from the other joint disease
- Concomitant SLE
- Chest x-ray shows evidence of TB.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01489384
Start Date
December 1 2011
End Date
September 1 2018
Last Update
April 13 2017
Active Locations (13)
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1
Rhumatologie Moncton
Moncton, New Brunswick, Canada, E1G 2K5
2
Eric N. Grant Professional Corp.
Quispamsis, New Brunswick, Canada, E2E 4J8
3
Bowmanville, Ontario, Canada, L1C 1P6
4
Dr.'s Nalin and Vandana Ahluwalia Medicine Professional Corp.
Brampton, Ontario, Canada, L6T 3J1