Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 16, 2010
April 7, 2011
August 2002
December 2008   (final data collection date for primary outcome measure)
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.
  • Evaluation of Adverse Events [ Time Frame: up to Wk 260 ] [ Designated as safety issue: Yes ]
  • Clinically Significant Laboratory Changes per Investigator's Discretion [ Time Frame: up to Wk 260 ] [ Designated as safety issue: Yes ]
  • Clinically Significant Physical Exam Changes per Investigator's Discretion [ Time Frame: up to Wk 260 ] [ Designated as safety issue: Yes ]
  • Clinically Significant Vital Sign Changes per Investigator's Discretion [ Time Frame: up to Wk 260 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01070303 on ClinicalTrials.gov Archive Site
  • 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.
  • Percentage of Subjects Achieving Clinical Remission [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving CR-70 [ Time Frame: : Week 260 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving CR-100 [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving Steroid-free Clinical Remission [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Achieving Steroid-free CR-100 [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
  • Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 248 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Fistula Remission [ Time Frame: Week 260 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Infection [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Serious Infection [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Lymphoma [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Malignancy [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Nonmelanoma Skin Cancer [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma) [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer) [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Injection Site Reaction-related Adverse Events [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis) [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Congestive Heart Failure [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Hepatic-related Adverse Events [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Demyelinating Disease [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Allergic Reaction-related Adverse Events [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Lupus-like Syndrome [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Hematologic-related Adverse Events [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With Fatal Adverse Events [ Time Frame: Week 0 of Study M02-403 through Week 260 of Study M02-433 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Remission in Subjects With Crohn's Disease, Open Label Extension
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

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.

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).

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
Biological: Adalimumab 40 mg eow or ew
Adalimumab 40 mg by subcutaneous injection every other week or every week
Other Names:
  • Adalimumab
  • Humira
Experimental: Adalimumab 40 mg every other week or every week
Intervention: Biological: Adalimumab 40 mg eow or ew
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
177
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01070303
M02-433 Open Label
No
Anne Camez, Medical Director, Abbott
Abbott
Not Provided
Study Director: Anne Camez, MD Abbott
Abbott
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP