Long Term Open Label Continuation Study

Abbott

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: Adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195650

DE020

Details and patient eligibility

About

The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.

Full description

Study DE020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior Phase 1, 2, or 3 adalimumab study in the United States or Canada, had a favorable safety and efficacy profile when treated with adalimumab, and met the eligibility criteria for the continuation study. Participants received subcutaneous injections of adalimumab every other week (eow) or monthly based on the adalimumab regimen received in the prior study (i.e., participants who received monthly dosing in the prior study began the continuation study on monthly dosing; all other participants began adalimumab dosing at eow intervals). Participants who maintained an American College of Rheumatology 50% (ACR50) response for 2 consecutive visits could have their dosing interval lengthened to a monthly dosing schedule. Safety and efficacy data were collected over 520 weeks (10 years). Both safety and efficacy data were analyzed using all participants who received at least 1 dose of open-label adalimumab in the 10-year continuation study DE020 (the Full Analysis Set, n=846). Three patients who entered the continuation study but were never dosed were excluded from all analyses.

Enrollment

846 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participant was in a prior D2E7 (adalimumab) study
Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.

Exclusion Criteria

Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study
Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant
Participant had any ongoing chronic or active infection