Remission in Subjects With Crohn's Disease, Open Label Extension (CLASSICII)

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT01070303
First received: February 16, 2010
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Biological: Adalimumab 40 mg eow or ew
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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). [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303). [ Time Frame: Week 152 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303). [ Time Frame: Week 212 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303). [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 104 ] [ Designated as safety issue: No ]
    A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 152 ] [ Designated as safety issue: No ]
    A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 212 ] [ Designated as safety issue: No ]
    A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating a significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 260 ] [ Designated as safety issue: No ]
    A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303) [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
    A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in Study to Week 152 ] [ Designated as safety issue: No ]
    A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 212 ] [ Designated as safety issue: No ]
    CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 260 ] [ Designated as safety issue: No ]
    A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. 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. Scores at Baseline of the lead-in study (NCT00055523), which were used to calculate clinical response, ranged from 201 to 450. A lower score indicates less severe Crohn's disease activity.

  • Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 104 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.

  • Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 152 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.

  • Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 212 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.

  • Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 260 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free remission was achieved if the participant stopped taking corticosteroids before the visit and had a CDAI score < 150 points at that visit.

  • Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 104 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.

  • Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 152 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.

  • Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 212 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.

  • Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 260 ] [ Designated as safety issue: No ]
    Among participants who were taking systemic corticosteroids at Baseline of the lead-in study (NCT00055523), steroid-free CR-100 was achieved if the participant stopped taking steroids before the visit and had a decrease from Baseline in CDAI score of 100 or more points at that visit.

  • Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores [ Time Frame: Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248 ] [ Designated as safety issue: No ]
    IBDQ is a validated disease−specific instrument that assesses the impact of IBD on patient quality of life during a 2−week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.

  • Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 104 ] [ Designated as safety issue: No ]
    A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.

  • Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 152 ] [ Designated as safety issue: No ]
    A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.

  • Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 212 ] [ Designated as safety issue: No ]
    A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.

  • Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303) [ Time Frame: From Baseline of lead-in study to Week 260 ] [ Designated as safety issue: No ]
    A count of the number of cutaneous fistulas draining upon gentle compression was performed at Baseline of the lead-in study (NCT00055523) and at study visits. Among participants with draining fistulas at Baseline of NCT00055523, a participant was considered to have achieved fistula remission at a study visit if the participant had no draining cutaneous fistulas at that visit.


Enrollment: 177
Study Start Date: August 2002
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab 40 mg every other week or every week Biological: Adalimumab 40 mg eow or ew
Adalimumab 40 mg by subcutaneous injection every other week or every week
Other Names:
  • Adalimumab
  • Humira

Detailed Description:

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).

Data are summarized for Remitters and Non-remitters, with the exception of data for primary reason for noncompletion. Summaries of primary reason for noncompletion were available only for all participants, not for Remitters and Non-remitters. Data are reported for Weeks 104, 152, 212, and 260 of Study M02-433, starting from Week 0 of NCT00055497; these weeks correspond to 1, 2, 3, and 4 years of participation in NCT01070303. Change from Baseline results (clinical response 70, clinical response 100, Inflammatory Bowel Disease Questionnaire, and fistula remission) are calculated from Baseline of the lead-in study (NCT00055523). Results on each assessment at each measurement time point are presented as individual outcome measures because different numbers of participants were evaluated at each time point (as observed analysis).

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant had completed the Year 1 of Study M02-433 (NCT00055497)
  • Diagnosis of Crohn's disease
  • Willing and able to give informed consent

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070303

  Show 43 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Anne Camez, MD Abbott
  More Information

No publications provided

Responsible Party: Anne Camez, Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT01070303     History of Changes
Other Study ID Numbers: M02-433 Open Label
Study First Received: February 16, 2010
Results First Received: March 11, 2010
Last Updated: April 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
HUMIRA
adalimumab
Inflammatory Bowel Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014