Control of Rheumatoid Arthritis (RA) by oral tolerance

ISRCTN	ISRCTN98945627
DOI	https://doi.org/10.1186/ISRCTN98945627
Protocol serial number	S0523
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ernest Choy
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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bovine type II collagen
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

Academic Department of Rheumatology

London
SE22 8PT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/09/2001		Yes	No