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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01021735
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : May 29, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: etanercept or adalimumab Drug: Rituximab Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimal Management of Rheumatoid Arthritis Patients Requiring Biologic Therapy
Study Start Date : April 2010
Primary Completion Date : December 2014
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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.

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021735


Locations
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
Investigators
Principal Investigator: Duncan Porter, BM BCh University of Glasgow
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duncan Porter, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT01021735     History of Changes
Other Study ID Numbers: 2009-011268-13
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Duncan Porter, University of Glasgow:
Rheumatoid
Outcome
Cost effectiveness
Safety

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Etanercept
Adalimumab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Immunosuppressive Agents