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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 302
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01021735

Contacts
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

Locations
United Kingdom
NHS Fife Not yet recruiting
Widygates, Fife, United Kingdom
Contact: John McLaren, MB ChB       john.mclaren2@nhs.net   
Principal Investigator: John McLaren, MB ChB         
NHS Lanarkshire Recruiting
Wishaw, Lanarkshire, United Kingdom
Contact: Robin Munro, MB ChB       robin.munro@lanarkshire.scot.nhs.uk   
Principal Investigator: Robin Munro, MB ChB         
Aberdeen Royal Infirmary Recruiting
Aberdeen, United Kingdom
Contact: Pradeep Kumar, MB ChB       pradeepkumar@nhs.net   
Principal Investigator: Pradeep Kumar, MB ChB         
Ninewells Hospital Recruiting
Dundee, United Kingdom
Contact: Vinod Kumar, MB ChB       kumar.vinod@nhs.net   
Principal Investigator: Vinod Kumar, MB ChB         
NHS Lothian Recruiting
Edinburgh, United Kingdom
Contact: Euan McRorie, MB ChB       Euan.McRorie@luht.scot.nhs.uk   
Principal Investigator: Euan McRorie, MB ChB         
Greater Glasgow & Clyde NHS Board Recruiting
Glasgow, United Kingdom
Contact: Duncan Porter, BMBCh    0044 141 211 3429    duncan.porter@ggc.scot.nhs.uk   
Sub-Investigator: David McCarey, MB ChB         
Principal Investigator: Duncan Porter, BM BCh         
Sub-Investigator: Anne McEntegart, MB ChB         
Sub-Investigator: David Marshall, MB ChB         
Raigmore Hospital Not yet recruiting
Inverness, United Kingdom
Contact: Malcolm Steven, MB ChB       malcolm.steven@nhs.net   
Principal Investigator: Malcolm Steven, MB ChB         
NHS Borders Recruiting
Melrose, United Kingdom
Contact: Ruth Richmond, MB ChB       ruth.richmond@borders.scot.nhs.uk   
Principal Investigator: Ruth Richmond, MB ChB         
Sponsors and Collaborators
University of Glasgow
Arthritis Research Campaign
NHS Lothian
NHS Grampian
NHS Tayside
NHS Lanarkshire
NHS Borders
NHS Fife
Investigators
Principal Investigator: Duncan Porter, BM BCh University of Glasgow
  More Information

No publications provided

Responsible Party: Duncan Porter, Senior Lecturer, University of Glasgow
ClinicalTrials.gov Identifier: NCT01021735     History of Changes
Other Study ID Numbers: 2009-011268-13
Study First Received: November 27, 2009
Last Updated: October 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by 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
TNFR-Fc fusion protein
Adalimumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014