Control of Rheumatoid Arthritis (RA) by oral tolerance
| ISRCTN | ISRCTN98945627 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98945627 |
| Secondary identifying numbers | S0523 |
- Submission date
- 18/07/2002
- Registration date
- 18/07/2002
- Last edited
- 04/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ernest Choy
Scientific
Scientific
Academic Department of Rheumatology
GKT School of Medicines
King's College Hospital (Dulwich)
East Dulwich Grove
London
SE22 8PT
United Kingdom
| Phone | +44 (0)20 7346 6446 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bovine type II collagen |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1998 |
| Completion date | 01/01/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 01/01/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Department of Rheumatology
London
SE22 8PT
United Kingdom
SE22 8PT
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2001 | Yes | No |
