Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Sponsor AbbVie (prior sponsor, Abbott)
Start date May 2011
End date November 2014
Trial size 125 participants
Trial identifier NCT01346501, P12-707

Summary

The objectives of this observational sudy are as follows. Main objective is to determine the ability to maintain response after discontinuation of adalimumab treatment.

Secondary objective is to determine radiographic progression in patients participating in the study, including the proportion who display minimal progression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Those with an exposure
Patients who discontinue adalimumab treatment after completion of the P12-069 study

Primary Outcomes

Measure
Disease activity Score 28
time frame: at week 26
Disease activity Score 28
time frame: at week 52
Disease activity Score 28
time frame: at week 78
Disease activity Score 28
time frame: at week 104
Matrix metalloprotease-3
time frame: at week 26
Matrix metalloprotease-3
time frame: at week 52
Matrix metalloprotease-3
time frame: at week 78
Matrix metalloprotease-3
time frame: at week 104
Health Assessment Questionnaire
time frame: at week 26
Health Assessment Questionnaire
time frame: at week 52
Health Assessment Questionnaire
time frame: at week 78
Health Assessment Questionnaire
time frame: at week 104

Secondary Outcomes

Measure
Number of patients with adverse events
time frame: at week 52
Number of patients with adverse events
time frame: at week 104
X-ray findings for hands and feet
time frame: at week 52
X-ray findings for hands and feet
time frame: at week 104

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - The participants will be patients who have continued the 1-year observational period of P12-069 study. Exclusion Criteria: - Patients who use biological agents other than adalimumab in the P12-069 observational period will be excluded from the HOPE3 study.

Additional Information

Official title An Extended Observational Study (P12-707: HOPE III Study) of Follow-up Survey (P12-069: HOPE II Study) of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by AbbVie.