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Rheumatoid ArthritisNCT01489384

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

An observational study of Rheumatoid Arthritis, run by Pope Research Corporation at 13 sites in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
How many people
125 participants
Where
13 sitesCanada
Study dates
Dec 2011to Sep 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Canada13 sites

  • Study site

    Bowmanville, Ontario, L1C 1P6

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

    Brampton, Ontario, L6T 3J1

  • Brockville Medical Centre

    Brockville, Ontario, K6V 5J9

  • The Arthritis Center

    Burlington, Ontario, L7L 0B7

  • St. Joseph's Health Care

    Guelph, Ontario, N1H 5H8

  • St-Joseph Health Center

    London, Ontario, N6A 4V2

  • N.R. Medical Clinic

    Markham, Ontario, L6E 0H7

  • Rhumatologie Moncton

    Moncton, New Brunswick, E1G 2K5

  • Institut de Rhumatologie de Montréal

    Montreal, Quebec, H2L 1S6

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

    Québec, Quebec, G1V 3M7

  • Centre de Rhumatologie St-Louis

    Québec, Quebec, G1W 4R4

  • Eric N. Grant Professional Corp.

    Quispamsis, New Brunswick, E2E 4J8

  • Arthur Karasik Medicine Professional Corporation

    Toronto, Ontario, M9C 5N2

Other trials in Canada

About this study

Official title: A Canadian Randomized Controlled Trial of DMARD Withdrawal in RA Patients Achieving Therapeutic Response With Cimzia + DMARD Combination Treatment.

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.

Read the 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 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).
Keywords
Rheumatoid arthritis, DAS28
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01489384
Study groupRoleWhat they receive
3 months: Discontinue vs continue DMARDSAt 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 18 months

Secondary outcomes (1)

  1. 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.

    Measured: At 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2011 (estimated)
  2. Study startDec 2011
  3. Primary completion27 Aug 2018 (estimated)
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01489384
Sponsor's protocol ID
PRC-06-2011
Other IDs
JSS-01-2013
Status last verified
Apr 2017
First submitted
7 Dec 2011
Last updated
13 Apr 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Pope Research Corporation at 13 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01489384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.

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