Phase IIa trial of interferon-beta-1a (Avonex) in patients with rheumatoid arthritis
| ISRCTN | ISRCTN03626626 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03626626 |
| Protocol serial number | N/A |
| Sponsor | Biogen Idec Inc. (USA) |
| Funder | Biogen Idec Inc. (USA) |
- 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
Scientific
1000 Welch Road, Suite 203
Palo Alto
94304
United States of America
Study information
| 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 (RA) |
| Intervention | Interferon-beta-1a 30 mcg (or matched placebo) intramuscularly each week for 24 weeks. |
| Intervention type | Drug |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Interferon-beta-1a (Avonex) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 22 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2003 |
Locations
Countries of recruitment
- United States of America
Study participating centre
1000 Welch Road, Suite 203
Palo Alto
94304
United States of America
94304
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/01/2004 | Yes | No |
