Condition category
Musculoskeletal Diseases
Date applied
22/10/2003
Date assigned
23/10/2003
Last edited
29/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Genovese

ORCID ID

Contact details

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

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

Sponsor information

Organisation

Biogen Idec Inc. (USA)

Sponsor details

14 Cambridge Center
Cambridge
02142
United States of America

Sponsor type

Industry

Website

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

  1. 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.

Additional files

Editorial Notes