A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Maintenance of Clinical Remission in Subjects With Crohn's Disease, Open Label Extension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 177
- 试验地点
- 84
- 主要终点
- Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).
研究概览
简要总结
The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate the long-term safety of adalimumab when administered to participants with Crohn's disease.
详细描述
Study M02-433 was designed to evaluate the efficacy and safety of adalimumab in the maintenance of clinical remission in patients with Crohn's disease (CD). The study consisted of 2 phases: 1. a 1-year phase (Week 0 to Week 56) (NCT00055497) that consisted of a randomized, double-blind, placebo-controlled portion with a concomitant open label (OL) portion, and 2. a long-term open-label extension (OLE) phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Participants who completed the lead-in study NCT00055523, were eligible to participate in the rollover study, NCT00055497. 176 participants were documented as having completed Year 1 (NCT00055497); however, 177 participants were still receiving study drug and were evaluated at Week 56 of NCT00055497; these participants are included in the OLE data (NCT01070303).
At Week 4 of NCT00055497, participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score <150 points) at Baseline of NCT00055497 and who remained in clinical remission at Week 4 ("Remitters") were randomized to receive 1 of 3 blinded treatments: placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg every week (ew). Participants who did not demonstrate clinical remission at Baseline of NCT00055497 or who were no longer in clinical remission at Week 4 of NCT00055497 ("Non-remitters") were assigned to receive OL adalimumab 40 mg eow. All study drug (placebo and active) was administered by subcutaneous (SC) injection.
At any time during Study NCT00055497, a participant receiving blinded study drug who developed a disease flare could be switched to OL adalimumab 40 mg eow. A participant receiving OL adalimumab 40 mg SC eow who developed a flare or was a non-responders could have had his/her dose increased to 40 mg SC ew.
After 1 year (Week 56 of NCT00055497), patients who were still participating could continue in the OLE phase (NCT01070303). Participants who were receiving blinded study drug were switched to OL adalimumab 40 mg SC eow, and participants who were receiving OL study drug continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or ew).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant had completed the Year 1 of Study M02-433 (NCT00055497)
- •Diagnosis of Crohn's disease
- •Willing and able to give informed consent
排除标准
- •Diagnosis of ulcerative colitis
- •Pregnancy or breastfeeding
- •Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists
- •Previous history of active tuberculosis or listeria infection
- •Previous history of cancer other than successfully treated skin cancer
研究组 & 干预措施
Adalimumab 40 mg every other week or every week
干预措施: Adalimumab 40 mg eow or ew (Biological)
结局指标
主要结局
Number of Participants Achieving Clinical Remission (Crohn's Disease Activity Index[CDAI] <150 Points) at Week 104 of Study M02-433 (Starting From Week 0 of NCT00055497) (Through 1 Year of Participation in NCT01070303).
时间窗: Week 104
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT01070303 was 0 to 464. A lower score indicates less severe Crohn's disease activity.
次要结局
- Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).(Week 260)
- Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 152)
- Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).(Week 152)
- Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).(Week 212)
- Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)(From Baseline of lead-in study to Week 104)
- Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 212)
- Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 260)
- Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)(Week 104)
- Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 260)
- Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores(Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248)
- Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)(From Baseline of lead-in Study to Week 152)
- Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 212)
- Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 260)
- Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 260)
- Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 212)
- Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)(From Baseline of lead-in study to Week 104)
- Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 152)
- Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 212)
- Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)(From Baseline of lead-in study to Week 104)
- Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 152)
- Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 212)
- Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)(From Baseline of lead-in study to Week 104)
- Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 152)
- Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)(From Baseline of lead-in study to Week 260)