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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 主要终点
- Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with RA who continued the one year observational period of study P12-069 and provided informed consent to participate in study P12-707.
排除标准
- •Participants with RA who used biological agents other than adalimumab in the one year observational period of study P12-069.
结局指标
主要结局
Percentage of Participants With Disease Activity Score 28 - C-Reactive Protein (DAS28-CRP) Score < 3.2 After Discontinuation of Adalimumab Treatment
时间窗: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, and Week 156
The DAS28-CRP, a combined index that measured Rheumatoid Arthritis (RA) disease activity, was calculated based on the number of tender joint count (28 joints), the number of swollen joint count (28 joints), overall disease activity (using visual analog scale (VAS)), erythrocyte sedimentation rate (ESR), and C-Reactive protein (CRP). The DAS28-CRP scores ranged from 0 (no disease activity) to 9 (maximal disease activity); decrease in DAS28-CRP score indicated improvement of disease. In participants who discontinued treatment with adalimumab after sustained low disease activity (defined as DAS28-CRP score \<3.2) in study M06-859, the percentage of participants who maintained DAS28-CRP score \< 3.2 without disease flare (defined as DAS28-CRP score ≥ 3.2) during studies P12-069 and P12-707 was calculated.
Percentage of Participants With Positive Serum Level of Matrix Metalloprotease-3 (MMP-3)
时间窗: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208
MMP-3, a proteolytic enzyme that plays a pivotal role in joint destruction in RA was assessed during the study. MMP-3 serum level \< 121 ng/mL in men and \< 59.7 ng/mL in women was considered as the normal value. Data are presented as the percentage of participants with MMP-3 serum level greater than the normal value.
Mean Health Assessment Questionnaire (HAQ) Score
时间窗: At Week 0, Week 26, Week 52, Week 78, Week 104, Week 130, Week 156, Week 182, and Week 208
The HAQ score was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past seven days using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0-1 represented mild disability and 2-3 represented severe disability. Data are presented as mean HAQ score +/- standard deviation with negative scores indicating improvement.
次要结局
- Percentage of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions(From signing of informed consent until withdrawal of participant or starting a new biologic agent or up to approximately 2 years)
- Percentage of Participants With Modified Total Sharp Score (mTSS) ≤ 0.5 and ≤ 1.5(3 years)