| Source of record | UK Trials |
| ISRCTN | ISRCTN98945627 |
| Date ISRCTN assigned | 18/07/2002 |
| Local reference number(s) | S0523 |
| Public title | Control of Rheumatoid Arthritis (RA) by oral tolerance |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Rheumatoid arthritis |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 01/01/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11592359 |
| Sources of funding | Arthritis Research Campaign (UK) |
| Sponsor name | Arthritis Research Campaign (UK) |
| Sponsor details | Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
United Kingdom
S41 7TD |
| Sponsor email | info@arc.org.uk |
| Sponsor website | http://www.arc.org.uk |
| Contact name | Dr Ernest Choy |
| Contact details | Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
United Kingdom
SE22 8PT |
| Contact telephone | +44 (0)20 7346 6446 |
| Contact fax | +44 (0)20 7346 6475 |
| Contact email | ernest.choy@kcl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN98945627 |
| Date last extracted from ISRCTN register | 17/04/2008 |
