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Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01117480
First received: May 4, 2010
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The REACH study is conducted to describe the clinical effectiveness of adalimumab (HUMIRA) in subjects with moderately to severely active Rheumatoid Arthritis (RA) that are receiving anti-rheumatic treatments including adalimumab.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2005
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA patients that are receiving anti-rheumatic treatments

Detailed Description:

There is no interventional implications in this study. Data collection is recorded on the appropriate Case Report Forms. The data collected consist of: patient demographics (gender, race, age, weight), medical history of previous anti-rheumatic medication, Health Assessment Questionnaire (HAQ), Disease Activity Score 28 (DAS-28), joint assessment, Erythrocyte sedimentation rate (ESR) and patient healthcare questionnaires. A total 1000 patients will be enrolled in the study at up to 150 sites across Canada. It is anticipated that approximately 5 subgroups of patients will be identified. With 200 patients per sub-group, we will be able to produce estimates of the proportion reaching the target DAS-28 of less than 2.6 within ± 6 % in each end of the 95% confidence interval.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Rheumatoid Arthritis clinics and hospitals

Criteria

Inclusion Criteria:

  • Patient is eligible to take part in the registry as per the product monograph.
  • Patients that are naïve to adalimumab therapy / or patients that have been receiving adalimumab therapy for less than 4 months.
  • Patient is 18 years of age or older.
  • Patient has moderately to severely active RA.
  • Patient who has had an inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs).
  • Patient received provincial or private (insurance companies) approval for adalimumab.
  • Patient is able to give written informed consent and to understand the survey requirements.

Exclusion Criteria:

  • Patient to whom a traditional DMARD had never been tried.
  • Patient with a known hypersensitivity to adalimumab, or any of its components.
  • Patient is receiving free adalimumab as part of a compassionate program or an early access drug distribution program.
  • Patient with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes.
  • Patient with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the patient will not be available for a period of time (> 12 months) while being enrolled in the survey.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117480

  Show 79 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
University Health Network, Toronto
Investigators
Study Director: Linda Assouline, PhD AbbVie Corporation
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01117480     History of Changes
Other Study ID Numbers: PMOS-CANA-04-01
Study First Received: May 4, 2010
Last Updated: May 2, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
Moderately to severely active Rheumatoid Arthritis
adalimumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013