Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
This study is ongoing, but not recruiting participants.
Sponsor:
AbbVie (prior sponsor, Abbott)
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
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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:
MedlinePlus related topics:
Rheumatoid Arthritis
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
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Hide Study LocationsLocations
| Canada | |
| Site Reference ID/Investigator# 47667 | |
| Bowmanville, Canada, L1C 1P6 | |
| Site Reference ID/Investigator# 38057 | |
| Brampton, Canada, L6T 3J1 | |
| Site Reference ID/Investigator# 37506 | |
| Brampton, Canada, L6T 3J1 | |
| Site Reference ID/Investigator# 37515 | |
| Brampton, Canada, L6T 3J1 | |
| Site Reference ID/Investigator# 52149 | |
| Burnaby, Canada, V5H 3P2 | |
| Site Reference ID/Investigator# 37514 | |
| Calgary, Canada, T2P 3C5 | |
| Site Reference ID/Investigator# 37504 | |
| Calgary, Canada, T1Y 6H6 | |
| Site Reference ID/Investigator# 37531 | |
| Calgary, Canada, T2S 0J2 | |
| Site Reference ID/Investigator# 37521 | |
| Calgary, Canada, T2E 2R2 | |
| Site Reference ID/Investigator# 37516 | |
| Calgary, Canada, T2P 0V2 | |
| Site Reference ID/Investigator# 52154 | |
| Cranbrook, Canada, V1C 2R8 | |
| Site Reference ID/Investigator# 58484 | |
| Downsview, Canada, M3N 2V7 | |
| Site Reference ID/Investigator# 37536 | |
| Edmonton, Canada, T5K 2A2 | |
| Site Reference ID/Investigator# 37535 | |
| Edmonton, Canada, T5M 0H4 | |
| Site Reference ID/Investigator# 37505 | |
| Edmonton, Canada, T5M 0H4 | |
| Site Reference ID/Investigator# 37520 | |
| Edmonton, Canada, T5R 1W2 | |
| Site Reference ID/Investigator# 37541 | |
| Edmonton, Canada, T5M 0H4 | |
| Site Reference ID/Investigator# 37525 | |
| Fredericton, Canada, E3B 6H5 | |
| Site Reference ID/Investigator# 37503 | |
| Fredericton, Canada, E3B 6H5 | |
| Site Reference ID/Investigator# 38063 | |
| Guelph, Canada, N1H 5H8 | |
| Site Reference ID/Investigator# 38068 | |
| Hamilton, Canada, L8N 1Y2 | |
| Site Reference ID/Investigator# 55124 | |
| Hamilton, Canada, L8N 1Y2 | |
| Site Reference ID/Investigator# 38060 | |
| Hamilton, Canada, L8N 2B6 | |
| Site Reference ID/Investigator# 47662 | |
| Hamilton, Canada, L8N 1Y2 | |
| Site Reference ID/Investigator# 38062 | |
| Kamloops, Canada, V2C 6G6 | |
| Site Reference ID/Investigator# 54102 | |
| Kamloops, Canada, V2C 6L1 | |
| Site Reference ID/Investigator# 52152 | |
| Kelowna, Canada, V1W 4V5 | |
| Site Reference ID/Investigator# 37526 | |
| Kitchener, Canada, N2M 5N6 | |
| Site Reference ID/Investigator# 47674 | |
| Laval, Canada, H7T 2P5 | |
| Site Reference ID/Investigator# 64043 | |
| Levis, Canada, G6V 3Z1 | |
| Site Reference ID/Investigator# 47670 | |
| Lunenburg, Canada, B0J 2C0 | |
| Site Reference ID/Investigator# 37522 | |
| Mississauga, Canada, L5M 2V8 | |
| Site Reference ID/Investigator# 37510 | |
| Mississauga, Canada, L5B 4A2 | |
| Site Reference ID/Investigator# 37502 | |
| Montreal, Canada, H2L 1S6 | |
| Site Reference ID/Investigator# 37539 | |
| Montreal, Canada, H3Z 2Z3 | |
| Site Reference ID/Investigator# 37527 | |
| Montreal, Canada, H1Y 1A9 | |
| Site Reference ID/Investigator# 37532 | |
| Montreal, Canada, H3T 1Y3 | |
| Site Reference ID/Investigator# 37537 | |
| Montreal, Canada, H3T 1Y3 | |
| Site Reference ID/Investigator# 60122 | |
| Montreal, Canada, H1T 2M4 | |
| Site Reference ID/Investigator# 72494 | |
| Montreal, Canada, H4S 1R5 | |
| Site Reference ID/Investigator# 47663 | |
| Montreal, Canada, H3T 1E2 | |
| Site Reference ID/Investigator# 38069 | |
| Nanaimo, Canada, V9S 4S1 | |
| Site Reference ID/Investigator# 37513 | |
| Nepean, Canada, K2G 6E2 | |
| Site Reference ID/Investigator# 37542 | |
| Newmarket, Canada, L3Y 3R7 | |
| Site Reference ID/Investigator# 52148 | |
| North Vancouver, Canada, V7M 1R9 | |
| Site Reference ID/Investigator# 54103 | |
| North York, Canada, M3N 2V6 | |
| Site Reference ID/Investigator# 37524 | |
| Ottawa, Canada, K2P 1V3 | |
| Site Reference ID/Investigator# 37507 | |
| Ottawa, Canada, K2H 9A5 | |
| Site Reference ID/Investigator# 38070 | |
| Ottawa, Canada, K2G 6E2 | |
| Site Reference ID/Investigator# 37523 | |
| Outremont, Canada, H2V 3Z5 | |
| Site Reference ID/Investigator# 37533 | |
| Owen Sound, Canada, N4K 4K7 | |
| Site Reference ID/Investigator# 38066 | |
| Penticton, Canada, V2A 3G8 | |
| Site Reference ID/Investigator# 37538 | |
| Penticton, Canada, V2A 3G7 | |
| Site Reference ID/Investigator# 37529 | |
| Peterborough, Canada, K9J 783 | |
| Site Reference ID/Investigator# 47672 | |
| Prince George, Canada, V2L 5B6 | |
| Site Reference ID/Investigator# 47664 | |
| Rimouski, Canada, G5L 8W1 | |
| Site Reference ID/Investigator# 37518 | |
| Scarborough, Canada, M1B 4Y9 | |
| Site Reference ID/Investigator# 38059 | |
| Sherbrooke, Canada, J1H 1Z1 | |
| Site Reference ID/Investigator# 47676 | |
| Sherbrooke, Canada, J1H 5N4 | |
| Site Reference ID/Investigator# 37534 | |
| St. Catharines, Canada, L2N 7E4 | |
| Site Reference ID/Investigator# 37528 | |
| St. Eustache, Canada, J7P 4J2 | |
| Site Reference ID/Investigator# 37530 | |
| St. John's, Canada, A1C 5B8 | |
| Site Reference ID/Investigator# 37511 | |
| St. John's, Canada, A1A 5E8 | |
| Site Reference ID/Investigator# 38065 | |
| Toronto, Canada, M5T 3A9 | |
| Site Reference ID/Investigator# 47668 | |
| Toronto, Canada, M9V 4B8 | |
| Site Reference ID/Investigator# 35722 | |
| Toronto, Canada, M4X 1W4 | |
| Site Reference ID/Investigator# 38058 | |
| Toronto, Canada, M4N 3M5 | |
| Site Reference ID/Investigator# 37509 | |
| Toronto, Canada, M5G 1N8 | |
| Site Reference ID/Investigator# 37508 | |
| Toronto, Canada, M9C 5N2 | |
| Site Reference ID/Investigator# 47678 | |
| Toronto, Canada, M6S 4W4 | |
| Site Reference ID/Investigator# 47665 | |
| Trois-Rivieres, Canada, G8Z 1Y2 | |
| Site Reference ID/Investigator# 52151 | |
| Vancouver, Canada, V5Z 3Y1 | |
| Site Reference ID/Investigator# 43122 | |
| Vancouver, Canada, V6Z 2E8 | |
| Site Reference ID/Investigator# 37540 | |
| Vancouver, Canada, V6Z 2E8 | |
| Site Reference ID/Investigator# 37519 | |
| Victoria, Canada, V8P 5P6 | |
| Site Reference ID/Investigator# 37517 | |
| Victoria, Canada, V8V 3P9 | |
| Site Reference ID/Investigator# 52147 | |
| Windsor, Canada, N8X 4T2 | |
| Site Reference ID/Investigator# 37512 | |
| Winnipeg, Canada, R3A 1M3 | |
| Site Reference ID/Investigator# 54105 | |
| Winnipeg, Canada, R2M 5L6 | |
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: | 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 16, 2013