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Completed

NCT Number: NCT01070303

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gastroenterology Associates of the East Bay, Berkeley, California, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab 40 mg eow or ew

Biological

Adalimumab 40 mg by subcutaneous injection every other week or every week

Other names: Adalimumab, Humira

Primary outcomes

  1. 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

    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 outcomes

  1. Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).

    Time frame: Week 152

    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.

  2. Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).

    Time frame: Week 212

    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.

  3. Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).

    Time frame: Week 260

    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.

  4. 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

    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.

  5. 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

    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.

  6. 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

    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.

  7. 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

    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.

  8. Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)

    Time frame: Week 104

    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.

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. 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

    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.

  14. 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

    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.

  15. 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

    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.

  16. 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

    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.

  17. 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

    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.

  18. 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

    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.

  19. 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

    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.

  20. Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores

    Time frame: Change from Baseline of lead-in study at Weeks 104, 152, 200, and 248

    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.

  21. 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

    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.

  22. 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

    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.

  23. 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

    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.

  24. 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

    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.

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study 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

Acronym: CLASSICII

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Feb 18, 2010
Registry last updated
Apr 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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