Crohn's Disease
Conditions
Brief summary
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.
Detailed description
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).
Interventions
BIOLOGICALDouble-blind (DB) adalimumab placebo
Double-blind nonactive matching subcutaneous injection
BIOLOGICALDB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every other week by subcutaneous injection
BIOLOGICALDB adalimumab 40 mg ew
Double-blind adalimumab 40 mg every week by subcutaneous injection
BIOLOGICALOL adalimumab 40 mg
Open-label adalimumab every other week or every week by subcutaneous injection
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Patient must have successfully completed the induction study NCT00055523 * Diagnosis of Crohn's disease * Willing and able to give informed consent Exclusion: * Diagnosis of ulcerative colitis * Pregnancy or breastfeeding * Previous use of infliximab or other anti-TNF antagonists * Previous history of active tuberculosis or listeria infection * Previous history of cancer other than successfully treated skin cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) | Week 56 | 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. |
| Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) | Week 56 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Clinical Remission at Week 24 - NRI | Week 24 | 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. |
| Number of OL Participants Achieving Clinical Remission at Week 56 - NRI | Week 56 | 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. |
| Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | From Baseline of lead-in study to Week 24 and Week 56 | 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. |
| Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | From Baseline of lead-in study to Week 24 and to Week 56 | 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. |
| Number of Participants Achieving Clinical Remission at Week 24 - LOCF | Week 24 | 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. |
| Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF | Week 56 | 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. |
| Number of Participants Achieving CR-100 - LOCF | From Baseline of lead-in study to Week 24 and Week 56 | 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. |
| Number of Participants Achieving CR-70 - LOCF | From Baseline of lead-in study to Week 24 and Week 56 | 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. |
| Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Change from Baseline of lead-in study to Week 24 and Week 56 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Study was rollover of NCT00055523; screening done in NCT00055523. At Week 4 of NCT00055497, 55 remitters at Week 0 and Week 4 of Study NCT00055497 were randomized to DB therapy; 204 non-remitters were assigned to OL adalimumab. 17 discontinued before/at Week 4, included in OL group for Participant Flow and AEs because they were not randomized.
Participants by arm
| Arm | Count |
|---|---|
| DB Placebo | 18 |
| DB Adalimumab 40 mg Every Other Week (Eow) | 19 |
| DB Adalimumab 40 mg Every Week | 18 |
| OL Adalimumab 40 mg Eow Participants who did not continue at Week 4 are not included in Baseline summary. | 204 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative Reasons | 0 | 0 | 0 | 1 |
| Overall Study | Adverse Event | 1 | 1 | 1 | 28 |
| Overall Study | Lack of Efficacy | 1 | 0 | 0 | 27 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 5 |
| Overall Study | Other | 0 | 0 | 0 | 11 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 1 | 15 |
Baseline characteristics
| Characteristic | DB Placebo | DB Adalimumab 40 mg Every Other Week (Eow) | DB Adalimumab 40 mg Every Week | OL Adalimumab 40 mg Eow | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 8 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 19 Participants | 18 Participants | 195 Participants | 249 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 9 Participants | 104 Participants | 137 Participants |
| Sex: Female, Male Male | 6 Participants | 7 Participants | 9 Participants | 100 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 18 | 15 / 19 | 14 / 18 | 190 / 221 |
| serious Total, serious adverse events | 2 / 18 | 1 / 19 | 0 / 18 | 37 / 221 |
Outcome results
Primary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) | Week 56 | 8 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) | Week 56 | 15 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF) | Week 56 | 15 Participants |
p-value: 0.029Fisher Exact
Primary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) | 6 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) | 9 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI) | 12 Participants |
p-value: 0.142Log Rank
Secondary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| DB Placebo | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 24 | 29.9 Scores on a scale |
| DB Placebo | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 56 | 24.7 Scores on a scale |
| DB Adalimumab 40 mg Every Other Week (Eow) | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 56 | 45.7 Scores on a scale |
| DB Adalimumab 40 mg Every Other Week (Eow) | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 24 | 43.4 Scores on a scale |
| DB Adalimumab 40 mg Every Week (ew) | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 24 | 51.9 Scores on a scale |
| DB Adalimumab 40 mg Every Week (ew) | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 56 | 45.2 Scores on a scale |
| OL Adalimumab 40 mg Eow | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 24 | 33.9 Scores on a scale |
| OL Adalimumab 40 mg Eow | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF | Week 56 | 36.0 Scores on a scale |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF | 93 Participants |
Secondary
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
Population: Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Number of OL Participants Achieving Clinical Remission at Week 56 - NRI | 74 Participants |
Secondary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants Achieving Clinical Remission at Week 24 - LOCF | Week 24 | 7 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving Clinical Remission at Week 24 - LOCF | Week 24 | 11 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving Clinical Remission at Week 24 - LOCF | Week 24 | 17 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving Clinical Remission at Week 24 - LOCF | Week 24 | 82 Participants |
p-value: 0.001Fisher Exact
Secondary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DB Placebo | Number of Participants Achieving Clinical Remission at Week 24 - NRI | 7 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving Clinical Remission at Week 24 - NRI | 11 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving Clinical Remission at Week 24 - NRI | 17 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving Clinical Remission at Week 24 - NRI | 74 Participants |
Secondary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 24 | 7 Participants |
| DB Placebo | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 56 | 6 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 56 | 9 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 24 | 11 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 24 | 17 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 56 | 13 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 24 | 110 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving Clinical Response 100 (CR-100) - NRI | Week 56 | 101 Participants |
Comparison: Week 24p-value: 0.33Fisher Exact
Comparison: Week 24p-value: 0.001Fisher Exact
Comparison: Week 56p-value: 0.508Fisher Exact
Comparison: Week 56p-value: 0.044Fisher Exact
Secondary
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
Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-70 not achieved) was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 56 | 6 Participants |
| DB Placebo | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 24 | 8 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 24 | 13 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 56 | 9 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 24 | 17 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 56 | 13 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 56 | 110 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving Clinical Response 70 (CR-70)- NRI | Week 24 | 123 Participants |
Comparison: Week 24p-value: 0.191Fisher Exact
Comparison: Week 24p-value: 0.003Fisher Exact
Comparison: Week 56p-value: 0.508Fisher Exact
Comparison: Week 56p-value: 0.004Fisher Exact
Secondary
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
Population: Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants Achieving CR-100 - LOCF | Week 24 | 7 Participants |
| DB Placebo | Number of Participants Achieving CR-100 - LOCF | Week 56 | 6 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving CR-100 - LOCF | Week 56 | 9 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving CR-100 - LOCF | Week 24 | 11 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving CR-100 - LOCF | Week 24 | 17 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving CR-100 - LOCF | Week 56 | 13 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving CR-100 - LOCF | Week 24 | 110 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving CR-100 - LOCF | Week 56 | 101 Participants |
Secondary
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
Population: Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF imputation was used for missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Placebo | Number of Participants Achieving CR-70 - LOCF | Week 24 | 15 Participants |
| DB Placebo | Number of Participants Achieving CR-70 - LOCF | Week 56 | 13 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving CR-70 - LOCF | Week 56 | 15 Participants |
| DB Adalimumab 40 mg Every Other Week (Eow) | Number of Participants Achieving CR-70 - LOCF | Week 24 | 18 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving CR-70 - LOCF | Week 24 | 17 Participants |
| DB Adalimumab 40 mg Every Week (ew) | Number of Participants Achieving CR-70 - LOCF | Week 56 | 16 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving CR-70 - LOCF | Week 24 | 144 Participants |
| OL Adalimumab 40 mg Eow | Number of Participants Achieving CR-70 - LOCF | Week 56 | 147 Participants |