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: April 8, 2014
Last verified: April 2014
  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:


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 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:
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: April 8, 2014
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 April 15, 2014