Cimzia Treatment in Rheumatoid Arthritis: Randomizing to Stop Versus Continue Disease-modifying Anti-rheumatic Drug(s)
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), or given as monotherapy (alone) over an 18 month period.
Approximately 300 patients with moderate to severe Rheumatoid Arthritis (RA) who are being prescribed Cimzia will be enrolled into the study.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Canadian Randomized Controlled Trial (RCT) of Real World Cimzia Treatment in RA: Randomizing to Stop Versus Continue DMARDs|
- The percentage of patients achieving DAS28<3.2 [ Time Frame: At 18 months ] [ Designated as safety issue: No ]Between-group differences with respect to the proportion of subjects achieving DAS28<3.2 will be assessed for statistical significance with the Chi-square test. Multiple-logistic regression model with terms for treatment group and potential confounders will be used to produce adjusted estimates of the relative rate of achieving therapeutic effectiveness. Time to achieving DAS28<3.2 will be assessed with Kaplan Meier survival analysis.
- Mean absolute change in DAS28 at 18 months [ Time Frame: At 18 months ] [ Designated as safety issue: No ]Between-group differences will be assessed for statistical significance with One Way ANOVA. General Linear Models will be used to adjust the between-group differences for potential confounders identified during the assessment of the baseline and demographic characteristics.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
3 months: Discontinue vs continue DMARDS
At 3 months those patients who achieved a change in DAS28 of 1.2 or greater will be randomized to discontinue versus continue DMARDs and will be followed for an additional 15 months
6 months: discontinue vs continue DMARDs
At 6 months, those patients still on Cimzia and DMARD therapy who were not randomized at month 3 AND achieve a change in DAS28> 1.2 will be randomized to discontinue versus continue DMARDs and will be followed for an additional 12 months.
6 months: discontinue vs continue DMARDs if change in DAS28
At 6 months, if the change in DAS28 is at least 0.6 and there is a decision to continue Cimzia, then the patients will be randomized to discontinue versus continue DMARDs with Cimzia and will be followed for an additional 12 months.
6 months: stop CIMZIA and treat as per standard of care
If a change in DAS28 of <0.6 occurs at 6 months in patients not randomized at month 3 then the patient will stop Cimzia and treatment will be standard of care. However, patient will still be followed until the end of study.
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 result in pain, swelling and joint damage with secondary deformity and progressive disability and impairment of patient's health related quality of life. It is estimated that about 1% of the population worldwide has RA.
Treatment for RA includes use of nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) selective inhibitors, corticosteroids and DMARDs. The effectiveness and toxicities associated with use of DMARDs differs based on the individual agent; DMARDs are often partially effective. For those in whom DMARDs have not fully treated RA, TNF inhibitors are often prescribed.
TNFα plays an important role in RA. Activities ascribed to TNFα in RA include recruitment and activation of polymorphonuclear leukocytes (PMNs), cellular proliferation, increased prostaglandin and matrix-degrading protease activity, and bone and cartilage resorption.
CIMZIA (certolizumab pegol) in combination with methotrexate (MTX) is indicated for:
• reducing signs and symptoms, inducing major clinical response, and reducing the progression of joint damage as assessed by X-ray, in adult patients with moderately to severely active rheumatoid arthritis (RA).
|Contact: Janet Pope, MD||519-646-6000||Janet.Pope@sjhc.london.on.ca|
|Canada, New Brunswick|
|Eric N. Grant Professional Corp.||Recruiting|
|Quispamsis, New Brunswick, Canada, E2E 4J8|
|Bowmanville, Ontario, Canada, L1C 1P6|
|Dr.'s Nalin and Vandana Ahluwalia Medicine Professional Corp.||Recruiting|
|Brampton, Ontario, Canada, L6T 3J1|
|Brockville Medical Centre||Recruiting|
|Brockville, Ontario, Canada, K6V 5J9|
|St. Joseph's Health Care||Recruiting|
|Guelph, Ontario, Canada, N1H 5H8|
|Arthur Karasik Medicine Professional Corporation||Not yet recruiting|
|Toronto, Ontario, Canada, M9C 5N2|
|Institut de Rhumatologie de Montréal||Recruiting|
|Montreal, Quebec, Canada, H2L 1S6|
|G.R.M.O. (Groupe de recherche en maladies oseuses) Inc.||Recruiting|
|Quebec, Canada, G1V 3M7|