Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01489384
Other study ID # PRC-06-2011
Secondary ID JSS-01-2013
Status Active, not recruiting
Phase N/A
First received December 7, 2011
Last updated April 12, 2017
Start date December 2011
Est. completion date September 2018

Study information

Verified date April 2017
Source Pope Research Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


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 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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 125
Est. completion date September 2018
Est. primary completion date August 27, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patient must be = 18 years of age.

2. Patient must be able to understand the information provided to them and to give written Informed Consent.

3. Patient must fulfill the old or new criteria for RA (see Appendix 1) or have a clinical diagnosis of RA.

4. 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.

5. If patient is on prednisone they must be on a stable dose (= 10 mg/day) for 1 month prior to baseline.

6. 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).

7. Patient must not have previously been exposed to Cimzia, however, previous anti-TNF exposure is allowed.

8. 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.

9. Patient must use Cimzia as per the dosing guidelines in the approved product monograph.

Exclusion Criteria:

1. Female patient who is breast-feeding or pregnant or does plan to become pregnant over the next year

2. Failure to use acceptable form of contraception in a pre-menopausal woman

3. Patient with concurrent serious liver disease

4. Patient with concurrent serious renal disease

5. Patient with significant hematological impairments

6. 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

7. Patient with a history of malignant lymphoma of leukemia

8. Patient with a history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. Multiple Sclerosis)

9. Patient with a history of untreated active tuberculosis

10. Patient with positive PPD (>5 mm) who have not had prophylaxis

11. Patient with a known positive HIV test

12. 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.

13. Patient with significant congestive heart failure

14. Patient with clinically significant concurrent medical of psychiatric disorders that in the physician's judgment may influence the study outcomes.

15. 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

16. Patient with severe noncompliance

17. Patient receiving an experimental product within the last 6 weeks prior to first dose of Cimzia.

18. Other joint disease or joint pain condition where the patient or physician cannot distinguish RA assessments from the other joint disease

19. Concomitant SLE

20. Chest x-ray shows evidence of TB.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Dr.'s Nalin and Vandana Ahluwalia Medicine Professional Corp. Brampton Ontario
Canada Brockville Medical Centre Brockville Ontario
Canada The Arthritis Center Burlington Ontario
Canada St. Joseph's Health Care Guelph Ontario
Canada St-Joseph Health Center London Ontario
Canada N.R. Medical Clinic Markham Ontario
Canada Rhumatologie Moncton Moncton New Brunswick
Canada Institut de Rhumatologie de Montréal Montreal Quebec
Canada Centre de Rhumatologie St-Louis Quebec
Canada G.R.M.O. (Groupe de recherche en maladies oseuses) Inc. Quebec
Canada Eric N. Grant Professional Corp. Quispamsis New Brunswick
Canada Arthur Karasik Medicine Professional Corporation Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Pope Research Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The percentage of patients achieving DAS28<3.2 or maintaining a change in DAS from baseline of = 1.2 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. At 18 months
Secondary Mean change from baseline in DAS28 score in each group 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. At 18 months
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4