NCT01021735

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

4.7 years

First QC Date

November 27, 2009

Last Update Submit

May 28, 2015

Conditions

Rheumatoid Arthritis

Keywords

RheumatoidOutcomeCost effectivenessSafety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Mean change in Health Assessment Questionnaire score

    12 months

  • Mean change in EQ5-D

    12 months

  • Mean QALY gain

    12 months

Study Arms (2)

Anti-TNF therapy

ACTIVE COMPARATOR

Etanercept or adalimumab by s/c injection

Drug: etanercept or adalimumab

Rituximab therapy

EXPERIMENTAL

Rituximab given by IV infusion

Drug: Rituximab

Interventions

etanercept or adalimumabDRUG

etanercept 50mg/week by s/c injection adalimumab 40mg eow by s/c/ injection

Also known as: Enbrel, Humira
Anti-TNF therapy
RituximabDRUG

1g x2 by IV infusion repeated every 5 months or more

Also known as: MabThera
Rituximab therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis
  • Eligible for biologic therapy according to BSR/NICE guidelines

You may not qualify if:

  • Prior biologic therapy
  • Contra-indication to anti-TNF therapy or rituximab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

NHS Fife

Widygates, Fife, United Kingdom

Location

NHS Lanarkshire

Wishaw, Lanarkshire, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Ninewells Hospital

Dundee, United Kingdom

Location

NHS Lothian

Edinburgh, United Kingdom

Location

Greater Glasgow & Clyde NHS Board

Glasgow, United Kingdom

Location

Raigmore Hospital

Inverness, United Kingdom

Location

NHS Borders

Melrose, United Kingdom

Location

Related Publications (1)

  • Porter D, van Melckebeke J, Dale J, Messow CM, McConnachie A, Walker A, Munro R, McLaren J, McRorie E, Packham J, Buckley CD, Harvie J, Taylor P, Choy E, Pitzalis C, McInnes IB. Tumour necrosis factor inhibition versus rituximab for patients with rheumatoid arthritis who require biological treatment (ORBIT): an open-label, randomised controlled, non-inferiority, trial. Lancet. 2016 Jul 16;388(10041):239-47. doi: 10.1016/S0140-6736(16)00380-9. Epub 2016 May 17.

    PMID: 27197690DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

EtanerceptAdalimumabRituximab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesAntibodies, Monoclonal, Murine-Derived

Study Officials

  • Duncan Porter, BM BCh

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

April 1, 2010

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

GB(8)