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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00234884




Registration number
NCT00234884
Ethics application status
Date submitted
16/09/2005
Date registered
10/10/2005
Date last updated
30/09/2011

Titles & IDs
Public title
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
Scientific title
A Five-year, Post-marketing Observational Study to Follow-up Patients With Rheumatoid Arthritis Formerly Treated in Study M02-497 (ReAct) and Subsequently Prescribed Humira
Secondary ID [1] 0 0
M03-634
Universal Trial Number (UTN)
Trial acronym
ReAlise
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - adalimumab

Adalimumab - RA patients in treatment with commercial adalimumab


Treatment: Other: adalimumab
commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR)
Timepoint [1] 0 0
Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
Primary outcome [2] 0 0
American College of Rheumatology 20% (ACR20) Response Rate
Timepoint [2] 0 0
Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
Primary outcome [3] 0 0
American College of Rheumatology 50% (ACR50) Response Rate
Timepoint [3] 0 0
Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
Primary outcome [4] 0 0
American College of Rheumatology 70% (ACR70) Response Rate
Timepoint [4] 0 0
Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value
Primary outcome [5] 0 0
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI)
Timepoint [5] 0 0
Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value

Eligibility
Key inclusion criteria
* Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
* Participants must have been willing to consent to data being collected and provided to Abbott.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
· Participants with contraindications according to the SmPC.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2010
Sample size
Target
Accrual to date
Final
3435
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Site Ref # / Investigator 5606 - Camperdown
Recruitment hospital [2] 0 0
Site Ref # / Investigator 49504 - New Lambton
Recruitment hospital [3] 0 0
Site Ref # / Investigator 49508 - Brisbane
Recruitment hospital [4] 0 0
Site Ref # / Investigator 49505 - Woodville
Recruitment hospital [5] 0 0
Site Ref # / Investigator 49503 - West Heidelberg
Recruitment hospital [6] 0 0
Site Ref # / Investigator 49502 - Cairns
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
4102 - Brisbane
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
3081 - West Heidelberg
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Bad Schallerbach
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Austria
State/province [2] 0 0
Graz
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Laab im Walde
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Linz
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Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.
Trial website
https://clinicaltrials.gov/study/NCT00234884
Trial related presentations / publications
Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.
Public notes

Contacts
Principal investigator
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Laura Redden, MD, PhD
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Abbott
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Contact person for public queries
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00234884