Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy (ORBIT)

This study is currently recruiting participants.
Verified October 2012 by University of Glasgow
Sponsor:
Collaborators:
Arthritis Research Campaign
NHS Lothian
NHS Grampian
NHS Tayside
NHS Lanarkshire
NHS Borders
NHS Fife
Information provided by (Responsible Party):
Duncan Porter, University of Glasgow
ClinicalTrials.gov Identifier:
NCT01021735
First received: November 27, 2009
Last updated: October 26, 2012
Last verified: October 2012

November 27, 2009
October 26, 2012
April 2010
June 2014   (final data collection date for primary outcome measure)
Mean change in Disease Activity Score (DAS28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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.
Mean change in Disease Activity Score (DAS28) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021735 on ClinicalTrials.gov Archive Site
  • Mean change in Health Assessment Questionnaire score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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
  • Mean change in EQ5-D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.
  • Mean QALY gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The cumulative gain in utility over 1 year (area under the curve) will be compared in the two groups
  • Mean change in Health Assessment Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean change in EQ5-D [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Mean QALY gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy
Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: etanercept or adalimumab
    etanercept 50mg/week by s/c injection adalimumab 40mg eow by s/c/ injection
    Other Names:
    • Enbrel
    • Humira
  • Drug: Rituximab
    1g x2 by IV infusion repeated every 5 months or more
    Other Name: MabThera
  • Active Comparator: Anti-TNF therapy
    Etanercept or adalimumab by s/c injection
    Intervention: Drug: etanercept or adalimumab
  • Experimental: Rituximab therapy
    Rituximab given by IV infusion
    Intervention: Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
302
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Duncan Porter, BM BCh 44 141 211 3262 duncan.porter@glasgow.ac.uk
Contact: kathleen Cowan 44 141 211 3262 kathleen.cowan@ggc.scot.nhs.uk
United Kingdom
 
NCT01021735
2009-011268-13
Yes
Duncan Porter, University of Glasgow
University of Glasgow
  • Arthritis Research Campaign
  • NHS Lothian
  • NHS Grampian
  • NHS Tayside
  • NHS Lanarkshire
  • NHS Borders
  • NHS Fife
Principal Investigator: Duncan Porter, BM BCh University of Glasgow
University of Glasgow
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP