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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=11592359
Publication citations
-
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.