Cimzia Treatment in Rheumatoid Arthritis: Randomizing to Stop Versus Continue Disease-modifying Anti-rheumatic Drug(s)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01489384|
Recruitment Status : Active, not recruiting
First Posted : December 9, 2011
Last Update Posted : April 13, 2017
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 monotherapy (alone) over an 18 month period.
Approximately 125 patients with moderate to severe Rheumatoid Arthritis (RA) who are being prescribed Cimzia will be enrolled into the study.
|Condition or disease|
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).
|Study Type :||Observational|
|Actual Enrollment :||125 participants|
|Official Title:||A Canadian Randomized Controlled Trial of DMARD Withdrawal in RA Patients Achieving Therapeutic Response With Cimzia + DMARD Combination Treatment.|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||August 27, 2018|
|Estimated Study Completion Date :||September 2018|
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
(Protocol amendment 4.0)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: D/C vs Cont'd DMARDs if change in DAS28
(Protocol amendment 4.0)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.
3 or 6 months: stop CIMZIA and treat as per SOC
(Protocol amendment 4.0)If a change in DAS28 of <0.6 occurs at 6 months (at 3 months for protocol amendment 6.1)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.
- The percentage of patients achieving DAS28<3.2 or maintaining a change in DAS from baseline of ≥ 1.2 at 18 months. [ Time Frame: At 18 months ]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 change from baseline in DAS28 score in each group at 18 months [ Time Frame: At 18 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489384
|Canada, New Brunswick|
|Moncton, New Brunswick, Canada, E1G 2K5|
|Eric N. Grant Professional Corp.|
|Quispamsis, New Brunswick, Canada, E2E 4J8|
|Bowmanville, Ontario, Canada, L1C 1P6|
|Dr.'s Nalin and Vandana Ahluwalia Medicine Professional Corp.|
|Brampton, Ontario, Canada, L6T 3J1|
|Brockville Medical Centre|
|Brockville, Ontario, Canada, K6V 5J9|
|The Arthritis Center|
|Burlington, Ontario, Canada, L7L 0B7|
|St. Joseph's Health Care|
|Guelph, Ontario, Canada, N1H 5H8|
|St-Joseph Health Center|
|London, Ontario, Canada, N6A 4V2|
|N.R. Medical Clinic|
|Markham, Ontario, Canada, L6E 0H7|
|Arthur Karasik Medicine Professional Corporation|
|Toronto, Ontario, Canada, M9C 5N2|
|Institut de Rhumatologie de Montréal|
|Montreal, Quebec, Canada, H2L 1S6|
|G.R.M.O. (Groupe de recherche en maladies oseuses) Inc.|
|Quebec, Canada, G1V 3M7|
|Centre de Rhumatologie St-Louis|
|Quebec, Canada, G1W 4R4|
|Principal Investigator:||Janet Pope, MD||Pope Research Corporation|