Condition category
Musculoskeletal Diseases
Date applied
15/12/2006
Date assigned
30/04/2007
Last edited
24/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paul Emery

ORCID ID

Contact details

c/o Dr Benazir Saleem
Academic Unit of Musculoskeletal Disease
2nd Floor
Chapel Allerton Hospital
Chapeltown Road
Leeds
LS7 4SA
United Kingdom
+44 (0)113 392 4883
benazir_saleem@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

OPRRA

Study hypothesis

The presence of sustained clinical remission is dependant on objective imaging and immunological characteristics of remission.

Ethics approval

Approval received from the Harrogate Local Research Ethics Committee on th 21st September 2005 (ref: 05/Q1107/57).

Study design

Prospective observational study of two cohorts: early rheumatoid arthritis patients, and established rheumatoid arthritis patients

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rheumatoid arthritis

Intervention

1. Withdrawal of anti-TNF therapy
2. Ultrasound of hands of dominant hand
3. Metacarpophalangeal joints two to five and wrist
4. X-ray of hands and feet
5. Blood tests for immunological assessment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The number of patients experiencing flare of disease at six months (defined as an increase in DAS28 more than 1.2 or to a total DAS more than 2.6).

Secondary outcome measures

1. Change in damage at six months when compared to baseline as measured by X-ray of both hands and feet (modified Sharpe Van de Heijde score) and ultrasound
2. Change in clinical and laboratory markers of disease activity, function and quality of life
3. Assessment of regulatory T cell levels in remission patients
4. Flare of disease by 12 months

Overall trial start date

01/12/2005

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 18 years
2. Male or female
3. American College of Rheumatology (ACR) diagnosis of rheumatoid arthritis
4. Stable Tumor Necrotising Factor (TNF) antagonist and concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs) (e.g. methotrexate treatment for six months)
5. Clinical remission for six months (at time of screening) as defined by Disease Activity Score (DAS28) less than 2.6
6. No clinical indication to change current treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Patients who are unwilling or unable to give consent
2. Patients who are pregnant

Recruitment start date

01/12/2005

Recruitment end date

01/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

c/o Dr Benazir Saleem
Leeds
LS7 4SA
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

c/o Clare Skinner
Research Grants Manager
School of Medicine
Leeds
LS2 9JT
United Kingdom
+44 (0)113 3434897
c.e.skinner@leeds.ac.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Industry

Funder name

Abbott Laboratories Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19565512
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20421345
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21242236

Publication citations

  1. Results

    Saleem B, Brown AK, Keen H, Nizam S, Freeston J, Karim Z, Quinn M, Wakefield R, Hensor E, Conaghan PG, Emery P, Disease remission state in patients treated with the combination of tumor necrosis factor blockade and methotrexate or with disease-modifying antirheumatic drugs: A clinical and imaging comparative study., Arthritis Rheum., 2009, 60, 7, 1915-1922, doi: 10.1002/art.24596.

  2. Results

    Saleem B, Keen H, Goeb V, Parmar R, Nizam S, Hensor EM, Churchman SM, Quinn M, Wakefield R, Conaghan PG, Ponchel F, Emery P, Patients with RA in remission on TNF blockers: when and in whom can TNF blocker therapy be stopped?, Ann. Rheum. Dis., 2010, 69, 9, 1636-1642, doi: 10.1136/ard.2009.117341.

  3. Results

    Saleem B, Brown AK, Keen H, Nizam S, Freeston J, Wakefield R, Karim Z, Quinn M, Hensor E, Conaghan PG, Emery P, Should imaging be a component of rheumatoid arthritis remission criteria? A comparison between traditional and modified composite remission scores and imaging assessments., Ann. Rheum. Dis., 2011, 70, 5, 792-798, doi: 10.1136/ard.2010.134445.

Additional files

Editorial Notes