Phase IIa trial of interferon-beta-1a (Avonex) in patients with rheumatoid arthritis

ISRCTN ISRCTN03626626
DOI https://doi.org/10.1186/ISRCTN03626626
Secondary identifying numbers N/A
Submission date
22/10/2003
Registration date
23/10/2003
Last edited
29/08/2007
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 Mark Genovese
Scientific

1000 Welch Road, Suite 203
Palo Alto
94304
United States of America

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRheumatoid arthritis (RA)
InterventionInterferon-beta-1a 30 mcg (or matched placebo) intramuscularly each week for 24 weeks.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II/III
Drug / device / biological / vaccine name(s)Interferon-beta-1a (Avonex)
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2002
Completion date01/01/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants22
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment01/01/2003

Locations

Countries of recruitment

  • United States of America

Study participating centre

1000 Welch Road, Suite 203
Palo Alto
94304
United States of America

Sponsor information

Biogen Idec Inc. (USA)
Industry

14 Cambridge Center
Cambridge
02142
United States of America

ROR logo "ROR" https://ror.org/02jqkb192

Funders

Funder type

Industry

Biogen Idec Inc. (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/01/2004 Yes No