Cimzia Treatment in Rheumatoid Arthritis: Randomizing to Stop Versus Continue Disease-modifying Anti-rheumatic Drug(s)

NCT01489384 | Unknown

• 2 other identifiers: PRC-06-2011JSS-01-2013
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 13

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 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; DAS28

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean change from baseline in DAS28 score in each group at 18 months

  At 18 months

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who had not had an adequate response to a DMARD therapy will have Cimzia added to their existing DMARD therapy at baseline and will be followed.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pope Research Corporation: lead

Study Sites (13)

Rhumatologie Moncton

Moncton, New Brunswick, E1G 2K5, Canada

Location

Eric N. Grant Professional Corp.

Quispamsis, New Brunswick, E2E 4J8, Canada

Location

Unknown Facility

Bowmanville, Ontario, L1C 1P6, Canada

Location

Dr.'s Nalin and Vandana Ahluwalia Medicine Professional Corp.

Brampton, Ontario, L6T 3J1, Canada

Location

Brockville Medical Centre

Brockville, Ontario, K6V 5J9, Canada

Location

The Arthritis Center

Burlington, Ontario, L7L 0B7, Canada

Location

St. Joseph's Health Care

Guelph, Ontario, N1H 5H8, Canada

Location

St-Joseph Health Center

London, Ontario, N6A 4V2, Canada

Location

N.R. Medical Clinic

Markham, Ontario, L6E 0H7, Canada

Location

Arthur Karasik Medicine Professional Corporation

Toronto, Ontario, M9C 5N2, Canada

Location

Institut de Rhumatologie de Montréal

Montreal, Quebec, H2L 1S6, Canada

Location

G.R.M.O. (Groupe de recherche en maladies oseuses) Inc.

Québec, Quebec, G1V 3M7, Canada

Location

Centre de Rhumatologie St-Louis

Québec, Quebec, G1W 4R4, Canada

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Janet Pope, MD

  Pope Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: December 1, 2011
• Primary Completion: August 27, 2018
• Study Completion: September 1, 2018
• Last Updated: April 13, 2017

Record last verified: 2017-04

Locations

CA (13)