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

This study has been completed.
Arthritis Research UK
NHS Lothian
NHS Grampian
NHS Tayside
NHS Borders
NHS Fife
Information provided by (Responsible Party):
Duncan Porter, University of Glasgow Identifier:
First received: November 27, 2009
Last updated: May 28, 2015
Last verified: May 2015
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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: etanercept or adalimumab
Drug: Rituximab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy

Resource links provided by NLM:

Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Mean change in Disease Activity Score (DAS28) [ Time Frame: 12 months ]
    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.

Secondary Outcome Measures:
  • Mean change in Health Assessment Questionnaire score [ Time Frame: 12 months ]
    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 ]
    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 ]
    The cumulative gain in utility over 1 year (area under the curve) will be compared in the two groups

Enrollment: 302
Study Start Date: April 2010
Study Completion Date: April 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anti-TNF therapy
Etanercept or adalimumab by s/c injection
Drug: etanercept or adalimumab
etanercept 50mg/week by s/c injection adalimumab 40mg eow by s/c/ injection
Other Names:
  • Enbrel
  • Humira
Experimental: Rituximab therapy
Rituximab given by IV infusion
Drug: Rituximab
1g x2 by IV infusion repeated every 5 months or more
Other Name: MabThera

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01021735

United Kingdom
NHS Fife
Widygates, Fife, United Kingdom
NHS Lanarkshire
Wishaw, Lanarkshire, 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
Sponsors and Collaborators
University of Glasgow
Arthritis Research UK
NHS Lothian
NHS Grampian
NHS Tayside
NHS Borders
NHS Fife
Principal Investigator: Duncan Porter, BM BCh University of Glasgow
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duncan Porter, Senior Lecturer, University of Glasgow Identifier: NCT01021735     History of Changes
Other Study ID Numbers: 2009-011268-13
Study First Received: November 27, 2009
Last Updated: May 28, 2015

Keywords provided by University of Glasgow:
Cost effectiveness

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Immunosuppressive Agents processed this record on May 22, 2017