Condition category
Musculoskeletal Diseases
Date applied
18/07/2002
Date assigned
18/07/2002
Last edited
04/10/2007
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

Dr Ernest Choy

ORCID ID

Contact details

Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom
+44 (0)20 7346 6446

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

S0523

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Rheumatoid arthritis

Intervention

Patients were randomly assigned to receive either 0.05 mg, 0.5 mg or 5 mg daily of bovine type II collagen (CII) or placebo for six months

Intervention type

Drug

Phase

Not Specified

Drug names

Bovine type II collagen

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1998

Overall trial end date

01/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

1. RA patients aged over 18 and fulfilling the 1987 American College of Rheumatology (ACR) criteria for the diagnosis of RA were entered into the study after giving their written informed consent
2. Patients must have had the disease at least two years and have failed at least one Slow Acting Anti-Rheumatic Drug (SAARD)
3. All the patients had to have active arthritis defined by the presence of three out of four clinical criteria: three or more swollen joints, six or more tender joints, early morning stiffness over 45 minutes and Erythrocyte Sedimentation Rate (ESR) over 28 mm/h. Oral steroid treatment was permitted if the dose was more than 10 mg/day

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1998

Recruitment end date

01/01/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Department of Rheumatology
London
SE22 8PT
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11592359

Publication citations

  1. Results

    Choy EH, Scott DL, Kingsley GH, Thomas S, Murphy AG, Staines N, Panayi GS, Control of rheumatoid arthritis by oral tolerance., Arthritis Rheum., 2001, 44, 9, 1993-1997, doi: 10.1002/1529-0131(200109)44:9<1993::AID-ART347>3.0.CO;2-A.

Additional files

Editorial Notes