A Phase 3 interventional study of Double-blind (DB) adalimumab placebo and DB adalimumab 40 mg eow in Crohn's Disease, sponsored by Abbott. Completed at 43 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-04-11.
Sponsored by Abbott · Phase 3, Interventional, and Treatment
The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of clinical remission up to 56 weeks in participants with Crohn's disease who participated in NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with Crohn's disease up to 56 weeks.
Study NCT00055497 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. the first year phase lasting until Week 56 and consisting of a randomized, double-blind (DB), placebo-controlled portion (NCT00055497) and of a concomitant open label (OL) portion, and 2. a long-term extension phase (NCT01070303) that lasted 264 additional weeks (Week 56 to Week 320).
Potential participants were screened at the time of enrollment in the lead-in, induction therapy study (NCT00055523). Participants who completed the lead-in study, NCT00055523, were eligible to participate in the rollover study, NCT00055497.
In Study NCT00055497, all participants received 40 mg of adalimumab subcutaneously (SC) at Baseline (Week 0) and Week 2 of Study NCT00055497. Baseline of Study NCT00055497 is synonymous with NCT00055523 Week 4. At Week 4 of Study NCT00055497, participants were randomized based on their clinical remission status at Baseline and Week 4 of Study NCT00055497. Participants who demonstrated clinical remission (defined as a Crohn's Disease Activity Index [CDAI] score \< 150 points) at Baseline of Study NCT00055497 and who remained in clinical remission at Week 4 of Study NCT00055497 (those participants constituted the randomized analysis set) were randomized to receive 1 of 3 blinded treatments: adalimumab 40 mg every other week (eow), adalimumab 40 mg every week (ew), or placebo. Participants who did not demonstrate clinical remission at Baseline of Study NCT00055497, or who were no longer in clinical remission at Week 4 of Study NCT00055497 were assigned to receive OL adalimumab 40 mg eow; those participants constituted the OL analysis set. At any time during Study NCT00055497, participants receiving OL adalimumab 40 mg SC eow who developed a flare or were non-responders during OL treatment could have had his/her dose increased to 40 mg SC weekly. Participants who were documented as having completed Week 56 are counted in the study completion total.
After 1 year (Week 56), participants who met eligibility criteria for the long-term extension phase (NCT01070303) were switched to OL adalimumab 40 mg subcutaneous (SC) eow, and participants previously in the OL treatment group of Study NCT00055497 continued on their previous OL adalimumab dose (adalimumab 40 mg SC eow or every week).
1,923 studies on the registry are indexed under Crohn Disease; 467 are open to participants now.
This study's enrollment of 276 is above the median of 66 across 1,212 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Abbott is the lead sponsor of 361 studies on the registry; 1 is open to participants now.
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Exclusion:
Double-blind nonactive matching subcutaneous injection
Biological: Double-blind (DB) adalimumab placebo
Double-blind adalimumab 40 mg eow by subcutaneous injection
Biological: DB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every week by subcutaneous injection
Biological: DB adalimumab 40 mg ew
Open-label adalimumab 40 mg eow or ew by subcutaneous injection
Biological: OL adalimumab 40 mg
Double-blind nonactive matching subcutaneous injection
Also known as: Humira®
Double-blind adalimumab 40 mg every other week by subcutaneous injection
Also known as: Humira®
Double-blind adalimumab 40 mg every week by subcutaneous injection
Also known as: Humira®
Open-label adalimumab every other week or every week by subcutaneous injection
Also known as: Humira®
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: Week 56
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: Week 56
Number of Participants Achieving Clinical Remission at Week 24 - NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: Week 56
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: From Baseline of lead-in study to Week 24 and to Week 56
Number of Participants Achieving Clinical Remission at Week 24 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: Week 24
Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: Week 56
Number of Participants Achieving CR-100 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: From Baseline of lead-in study to Week 24 and Week 56
Number of Participants Achieving CR-70 - LOCF
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Time frame: From Baseline of lead-in study to Week 24 and Week 56
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF
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.
Time frame: Change from Baseline of lead-in study to Week 24 and Week 56
276 participants were enrolled in the present study from 53 sites in the United States (US), Canada, Poland, Belgium, the Netherlands, and Czech Republic. The first visit in the present study for the first participant was 28 August 2002 and the final visit for the last participant occurred on 12 January 2005.
| Milestone | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) | OL Adalimumab 40 mg |
|---|---|---|---|---|
| Started | 18 | 19 | 18 | 221 |
| Completed | 13 | 16 | 16 | 131 |
| Not completed | 5 | 3 | 2 | 90 |
| Withdrew: Adverse event | 1 | 1 | 1 | 28 |
| Withdrew: Withdrawal by subject | 3 | 1 | 1 | 15 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 5 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 3 |
| Withdrew: Lack of efficacy | 1 | 0 | 0 | 27 |
| Withdrew: Administrative reasons | 0 | 0 | 0 | 1 |
| Withdrew: Other | 0 | 0 | 0 | 11 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Number of Participants Achieving Clinical Remission at Week 24 - NRI | 7 | 11 | 17 | 74 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | OL Adalimumab 40 mg |
|---|---|
| Number of OL Participants Achieving Clinical Remission at Week 56 - NRI | 74 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) |
|---|---|---|---|
| Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) | 6 | 9 | 12 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) |
|---|---|---|---|
| Week 56 | 8 | 15 | 15 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Eow | DB Adalimumab 40 mg ew | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Week 24 | 7 | 11 | 17 | 110 |
| Week 56 | 6 | 9 | 13 | 101 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Eow | DB Adalimumab 40 mg ew | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Week 24 | 8 | 13 | 17 | 123 |
| Week 56 | 6 | 9 | 13 | 110 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Week 24 | 7 | 11 | 17 | 82 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | OL Adalimumab 40 mg |
|---|---|
| Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF | 93 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Week 24 | 7 | 11 | 17 | 110 |
| Week 56 | 6 | 9 | 13 | 101 |
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 NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
| Participants | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Week 24 | 15 | 18 | 17 | 144 |
| Week 56 | 13 | 15 | 16 | 147 |
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.
| Scores on a scale | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week (ew) | OL Adalimumab 40 mg Eow |
|---|---|---|---|---|
| Week 24 | 29.9 (11.0 to 48.9) | 43.4 (27.7 to 59.2) | 51.9 (30.8 to 73.0) | 33.9 (29.7 to 38.1) |
| Week 56 | 24.7 (0.7 to 48.7) | 45.7 (27.1 to 64.4) | 45.2 (23.1 to 67.4) | 36.0 (31.3 to 40.6) |
Collected over Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB Placebo | — | 2/18 (11.1%) | 18/18 (100%) |
| DB Adalimumab 40 mg Eow | — | 1/19 (5.3%) | 15/19 (78.9%) |
| DB Adalimumab 40 mg ew | — | 0/18 (0%) | 14/18 (77.8%) |
| OL Adalimumab 40 mg | — | 37/221 (16.7%) | 190/221 (86%) |
| Event | DB Placebo | DB Adalimumab 40 mg Eow | DB Adalimumab 40 mg ew | OL Adalimumab 40 mg |
|---|---|---|---|---|
| Back painMusculoskeletal and connective tissue disorders | 1/18 | 0/19 | 0/18 | 0/221 |
| Ileal stenosisGastrointestinal disorders | 1/18 | 0/19 | 0/18 | 1/221 |
| Small intestinal obstructionGastrointestinal disorders | 1/18 | 0/19 | 0/18 | 3/221 |
| Coronary artery diseaseCardiac disorders | 0/18 | 1/19 | 0/18 | 0/221 |
| Crohn's diseaseGastrointestinal disorders | 0/18 | 0/19 | 0/18 | 9/221 |
| Abdominal abscessInfections and infestations | 0/18 | 0/19 | 0/18 | 2/221 |
| Anemia NOS aggravatedBlood and lymphatic system disorders | 0/18 | 0/19 | 0/18 | 2/221 |
| Ovarian cystReproductive system and breast disorders | 0/18 | 0/19 | 0/18 | 2/221 |
| AbscessInfections and infestations | 0/18 | 0/19 | 0/18 | 1/221 |
| Abscess intestinalInfections and infestations | 0/18 | 0/19 | 0/18 | 1/221 |
| Event | DB Placebo | DB Adalimumab 40 mg Eow | DB Adalimumab 40 mg ew | OL Adalimumab 40 mg |
|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 7/18 | 5/19 | 2/18 | 37/221 |
| Crohn's disease aggravatedGastrointestinal disorders | 5/18 | 4/19 | 2/18 | 39/221 |
| Viral infectionInfections and infestations | 0/18 | 4/19 | 0/18 | 6/221 |
| SinusitisInfections and infestations | 1/18 | 4/19 | 1/18 | 20/221 |
| ConstipationGastrointestinal disorders | 3/18 | 1/19 | 1/18 | 12/221 |
| Abdominal painGastrointestinal disorders | 3/18 | 1/19 | 0/18 | 20/221 |
| InfluenzaInfections and infestations | 1/18 | 3/19 | 1/18 | 14/221 |
| HeadacheNervous system disorders | 2/18 | 0/19 | 0/18 | 31/221 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/18 | 2/19 | 1/18 | 27/221 |
| Abdominal tendernessGastrointestinal disorders | 2/18 | 2/19 | 0/18 | 15/221 |
| Age, Categorical(Participants) | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week | OL Adalimumab 40 mg Eow | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 1 | 1 |
| Between 18 and 65 years | 17 | 19 | 18 | 195 | 249 |
| >=65 years | 1 | 0 | 0 | 8 | 9 |
| Sex: Female, Male(Participants) | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week | OL Adalimumab 40 mg Eow | Total |
|---|---|---|---|---|---|
| Female | 12 | 12 | 9 | 104 | 137 |
| Male | 6 | 7 | 9 | 100 | 122 |
The record gives a start of Aug 2002, a primary completion of Jan 2005 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.
Results were first posted in May 2010, 5 years 4 months after primary completion.
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This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adalimumab