NCT01585064

Brief Summary

The purpose of this trial is to assess the effect of two Intensive Outpatient Management Strategies (IOMS) versus Routine Care (RC) on the outcomes of patients with Rheumatoid Arthritis (RA) that are treated with adalimumab. This is a multi-center, randomized, controlled, parallel group, single (patient) blind trial. A total of 300 patients (100 per group) with RA will be recruited from approximately 40 sites across Canada.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
309

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2012

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

April 23, 2012

Last Update Submit

April 24, 2012

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis (RA)Anti-TNF therapyAdalimumabDisease activityTreating to target

Outcome Measures

Primary Outcomes (1)

  • Change in Disease Activity as measured by the DAS28 after 12 months of treatment

    The change in DAS28 will be calculated as an absolute and percent value. The percent change in DAS28 will the calculated as \[DAS28M12 - DAS28M0) / (DAS28M0} x 100% where: DAS28M12 is the DAS28 score at 12 months and - DAS28M0 is the DAS28 score at baseline. The DAS28 is a validated scale that measures disease activity in patients with rheumatic diseases. It is a composite scale that consists of the following: tender joint count, swollen joint count, ESR (mm/hr) and patient's global assessment of disease activity using a visual analog scale (VAS).

    Baseline (0) and Month 12

Secondary Outcomes (14)

  • Absolute and percent change in DAS28

    Baseline (0), Month 6, Month 12 and Month 18 (Study end)

  • Absolute and percent change in the Health Assessment Questionnaire (HAQ)

    Baseline (0), Month 6, Month 12 and Month 18 (Study end)

  • Absolute and percent change in individual components of the DAS28

    Baseline (0), Month 6, Month 12, Month 18 (Study End)

  • Percent achieving clinical remission defined as a DAS28 < 2.6

    Baseline (0), Month 6, Month 12, Month 18 (Study End)

  • Time to achieving clinical remission as measured by the DAS28 <2.6

    Baseline (0), Month 6, Month 12, Month 18 (Study End)

  • +9 more secondary outcomes

Study Arms (3)

DAS28-IOMS

Physicians randomized to the DAS28-IOMS will treat patients according to a protocol aimed at achieving a DAS28 score under 2.4.

Other: DAS28-IOMS

0SJ-IOMS

Physicians randomized to the 0SJ-IOMS will treat patients according to a protocol aimed at attaining a count of zero swollen joint (28 joints evaluated).

Other: 0SJ-IOMS

Routine Care (RC)

Physicians randomized to the RC group will treat study patients as per routine care and according to their own judgment.

Other: Routine Care (RC)

Interventions

DAS28-IOMSOTHER

Investigators randomized to DAS28-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a DAS28 score of \< 2.4.

DAS28-IOMS
0SJ-IOMSOTHER

Investigators randomized to 0SJ-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a swollen joint count of 0.

0SJ-IOMS
Routine Care (RC)OTHER

Investigators randomized to RC will NOT be expected to adapt their therapeutic approaches to a pre-defined target. They will optimize adalimumab treatment according to individual patient's responses to treatment as per routine care and according to their own judgment.

Routine Care (RC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients will be recruited from approximately 40 sites across Canada. The study sample selection will be stratified in order to ensure adequate representation from all Canadian regions.

You may qualify if:

  • Patient has a diagnosis of rheumatoid arthritis
  • Patient is \> 18 years of age
  • Patient is naïve to HUMIRA® (adalimumab) therapy.
  • Patient has access to reimbursement for their standard of care.
  • If female, patient is either: 1) not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or 2) of childbearing potential and practicing one of the following methods of birth control:
  • condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD)
  • contraceptives (oral or parenteral) for three months prior to enrollment in the study
  • a vasectomized partner
  • total abstinence from sexual intercourse
  • If female and of childbearing potential, patient must have a negative serum pregnancy test performed at Screening.
  • Patient is able to give written informed consent and to complete the survey requirements.

You may not qualify if:

  • Patients had a history of cancer within the past 5 years other than a successfully treated basal cell carcinoma and/or localized carcinoma in situ of the cervix
  • Patients with a history either of lymphoma or leukemia.
  • Patients with a history of untreated active tuberculosis, or listeriosis, or other currently active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic protozoal or fungal infections.
  • Patients with a known positive HIV test.
  • Patients with a known positive HepBsAg test.
  • Patients with a persistent or severe infection(s) requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days, prior to enrollment.
  • Female patients who are breast-feeding.
  • Patients with clinically significant concurrent illness that in the investigator's judgment may influence the study outcomes (such as MS, moderate to severe CHF, etc,).
  • Patients 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 (18 months).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lawson Health Research Institute

London, Ontario, N6A 4V2, Canada

Location

Related Publications (6)

  • Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001 Sep 15;358(9285):903-11. doi: 10.1016/S0140-6736(01)06075-5.

    PMID: 11567728BACKGROUND

  • Pincus T, Callahan LF. Taking mortality in rheumatoid arthritis seriously--predictive markers, socioeconomic status and comorbidity. J Rheumatol. 1986 Oct;13(5):841-5. No abstract available.

    PMID: 3820193BACKGROUND

  • Badley EM, Rasooly I, Webster GK. Relative importance of musculoskeletal disorders as a cause of chronic health problems, disability, and health care utilization: findings from the 1990 Ontario Health Survey. J Rheumatol. 1994 Mar;21(3):505-14.

    PMID: 8006895BACKGROUND

  • Grigor C, Capell H, Stirling A, McMahon AD, Lock P, Vallance R, Kincaid W, Porter D. Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial. Lancet. 2004 Jul 17-23;364(9430):263-9. doi: 10.1016/S0140-6736(04)16676-2.

    PMID: 15262104BACKGROUND

  • Pope JE, Haraoui B, Rampakakis E, Psaradellis E, Thorne C, Sampalis JS; Optimization of Adalimumab Trial Investigators. Treating to a target in established active rheumatoid arthritis patients receiving a tumor necrosis factor inhibitor: results from a real-world cluster-randomized adalimumab trial. Arthritis Care Res (Hoboken). 2013 Sep;65(9):1401-9. doi: 10.1002/acr.22010.

    PMID: 23509040DERIVED

  • Pope J, Thorne JC, Haraoui BP, Psaradellis E, Sampalis J. Do patients with active RA have differences in disease activity and perceptions if anti-TNF naive versus anti-TNF experienced? Baseline results of the optimization of adalimumab trial. Med Sci Monit. 2012 Aug;18(8):PI17-20. doi: 10.12659/msm.883250.

    PMID: 22847212DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Janet E Pope, MD MPH FRCPC

    Lawson Health Research Institute, Western University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

April 23, 2012

First Posted

April 25, 2012

Study Start

August 1, 2006

Primary Completion

December 1, 2009

Study Completion

February 1, 2010

Last Updated

April 25, 2012

Record last verified: 2012-04

Locations

CA(1)