Clinical trial NCT01346501: Special Investigation in Patients With Rheumatoid Arthritis (HOPEFUL III Study), a Follow-up Survey of Study P12-069
Official title: An Extended Observational Study (P12-707: HOPEFUL III Study) of Follow-up Survey (P12-069: HOPEFUL II Study) of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-05-03
Enrollment: 172
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Rheumatoid Arthritis (RA) who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.

Brief summary: The main objective of this study was to determine the ability to maintain response after discontinuation of adalimumab treatment and the secondary objective was to determine radiographic progression in participants participating in the study, including the percentage who displayed minimal progression.

Detailed description: This was a two-arm, multi-center, Post Marketing Observational Study (PMOS) conducted in Japanese participants with Rheumatoid Arthritis (RA) who continued the one year observational period of study P12-069 (HOPEFUL II study; NCT01163292) and provided informed consent to participate in study P12-707 (HOPEFUL III study; NCT01346501), after completion of study M06-859 (HOPEFUL I study; NCT00870467). The study P12-707 provided an additional two years of observation for those participants who participated in study P12-069.

Eligibility criteria: Inclusion Criteria:

Participants with RA who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.

Exclusion Criteria:

Participants with RA who used biological agents other than adalimumab in the one year observational period of study P12-069.

Primary outcomes:
measure: Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
timeFrame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156
measure: Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
timeFrame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208
measure: Mean Health Assessment Questionnaire (HAQ) Score
timeFrame: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208
Secondary outcomes:
measure: Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5
timeFrame: 3 years
measure: Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions
timeFrame: From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Sarina Kurimoto
role: STUDY_DIRECTOR
References:
citation: Tanaka Y, Yamanaka H, Ishiguro N, Miyasaka N, Kawana K, Kimura J, Agata N, Takeuchi T. Low disease activity for up to 3 years after adalimumab discontinuation in patients with early rheumatoid arthritis: 2-year results of the HOPEFUL-3 Study. Arthritis Res Ther. 2017 Mar 14;19(1):56. doi: 10.1186/s13075-017-1264-6.