NCT01585064|CompletedDMC
Loading search results
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Abbott Laboratories Ltd.
observational
309
1 country
1
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
February 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Actual (reported)February 2010
Actual (reported)April 23, 2012
Actual (reported)April 25, 2012
Actual (reported)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
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)
Physicians randomized to the DAS28-IOMS will treat patients according to a protocol aimed at achieving a DAS28 score under 2.4.
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).
Physicians randomized to the RC group will treat study patients as per routine care and according to their own judgment.
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.
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.
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.
Lawson Health Research Institute
London, Ontario, N6A 4V2, Canada
Lee DM, Weinblatt ME. Rheumatoid arthritis. Lancet. 2001 Sep 15;358(9285):903-11. doi: 10.1016/S0140-6736(01)06075-5.
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.
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.
Janet E Pope, MD MPH FRCPC
Lawson Health Research Institute, Western University
309 participants (actual enrollment reported by the registry).
First Submitted
April 23, 2012
First Posted
April 25, 2012
Study Start
August 2006
Date type not reportedThis date has not been verified as actual or estimated.
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
Primary Completion
December 2009
Actual (reported)Study Completion
February 2010
Actual (reported)Last Updated
April 25, 2012
Record last verified: 2012-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: