Rheumatoid Arthritis Clinical Trial
— ORBITOfficial title:
Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy
Verified date | May 2015 |
Source | University of Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: Research Ethics Committee |
Study type | Interventional |
That anti-TNF therapy and rituximab therapy are equally effective in treating patients with rheumatoid arthritis who meet the eligibility criteria for biologic therapy in the British Society for Rheumatology guidelines, and have not previously been exposed to biologic therapy.
Status | Completed |
Enrollment | 302 |
Est. completion date | April 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Rheumatoid arthritis - Eligible for biologic therapy according to BSR/NICE guidelines Exclusion Criteria: - Prior biologic therapy - Contra-indication to anti-TNF therapy or rituximab |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Aberdeen Royal Infirmary | Aberdeen | |
United Kingdom | Ninewells Hospital | Dundee | |
United Kingdom | NHS Lothian | Edinburgh | |
United Kingdom | Greater Glasgow & Clyde NHS Board | Glasgow | |
United Kingdom | Raigmore Hospital | Inverness | |
United Kingdom | NHS Borders | Melrose | |
United Kingdom | NHS Fife | Widygates | Fife |
United Kingdom | NHS Lanarkshire | Wishaw | Lanarkshire |
Lead Sponsor | Collaborator |
---|---|
University of Glasgow | Arthritis Research UK, NHS Borders, NHS Fife, NHS Grampian, NHS Lothian, NHS Tayside |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean change in Disease Activity Score (DAS28) | DAS28 is a composite measure of swollen joint count, tender joint count, patient global assessment of activity and ESR. The mean change in the DAS28 between 0 and 12 months in the two groups will be compared. | 12 months | No |
Secondary | Mean change in Health Assessment Questionnaire score | The HAQ uses a validated questionnaire that results in a disability score of between 0 and 3. The mean change in HAQ score between 0 and 12 months in the two groups will be compared | 12 months | No |
Secondary | Mean change in EQ5-D | EQ5-D is a validated questionnaire that gives a measure of utility. The mean change in the score between 0 and 12 months in the two groups will be compared. | 12 months | No |
Secondary | Mean QALY gain | The cumulative gain in utility over 1 year (area under the curve) will be compared in the two groups | 12 months | No |
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