Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
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 (RA)
Intervention
Interferon-beta-1a 30 mcg (or matched placebo) intramuscularly each week for 24 weeks.
Intervention type
Drug
Phase
Phase II/III
Drug names
Interferon-beta-1a (Avonex)
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2002
Overall trial end date
01/01/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Greater than 18 years old who meet the American College of Rheumatology criteria for Rheumatoid Arthritis (RA)
2. Failed at least one currently available Disease Modifying Anti-Rheumatic Drug (DMARD)
3. Active RA with greater than 6 swollen and 6 tender joints
4. C-Reactive Protein (CRP) exceeding 1.0 mg/dl
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
22
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2002
Recruitment end date
01/01/2003
Locations
Countries of recruitment
United States of America
Trial participating centre
1000 Welch Road, Suite 203
Palo Alto
94304
United States of America
Funders
Funder type
Industry
Funder name
Biogen Idec Inc. (USA)
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=14979940
Publication citations
-
Results
Genovese MC, Chakravarty EF, Krishnan E, Moreland LW, A randomized, controlled trial of interferon-beta-1a (Avonex(R)) in patients with rheumatoid arthritis: a pilot study [ISRCTN03626626]., Arthritis Res. Ther., 2004, 6, 1, R73-R77, doi: 10.1186/ar1026.