Trial Outcomes & Findings for Remission in Subjects With Crohn's Disease, Open Label Extension (NCT NCT01070303)

Last Updated: 2011-04-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

177 participants

Primary outcome timeframe

Week 104

Results posted on

2011-04-11

Participant Flow

Participants who were still receiving study drug and were evaluated at Week 56 of Study M02-433 (NCT00055497) are included in the open-label extension (OLE) (NCT01070303). Participants entered NCT00055497 from a lead-in adalimumab induction therapy study (NCT00055523).

Clinical remission = CDAI \<150. At Week 4 of NCT00055497, "remitters" (participants in clinical remission at Week 0 and Week 4 of NCT00055497) were randomized to double blind (DB) therapy and "non-remitters" (participants not in clinical remission at Week 0 or no longer in clinical remission at Week 4) were assigned to open-label (OL) adalimumab.

Participant milestones

Participant milestones
Measure	All Participants in Open-Label Extension of Study M02-433 Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
Overall Study STARTED	177
Overall Study COMPLETED	88
Overall Study NOT COMPLETED	89

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants in Open-Label Extension of Study M02-433 Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
Overall Study Adverse Event	39
Overall Study Withdrawal by Subject	20
Overall Study Lost to Follow-up	9
Overall Study Protocol Violation	0
Overall Study Lack of Efficacy	2
Overall Study Administrative Reason	1
Overall Study Other	18

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Remitters n=45 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=132 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Total n=177 Participants Total of all reporting groups
Age Continuous	35.5 years STANDARD_DEVIATION 10.88 • n=93 Participants	38.9 years STANDARD_DEVIATION 12.53 • n=4 Participants	38.1 years STANDARD_DEVIATION 12.19 • n=27 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	60 Participants n=4 Participants	86 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	72 Participants n=4 Participants	91 Participants n=27 Participants
Region of Enrollment United States	45 participants n=93 Participants	132 participants n=4 Participants	177 participants n=27 Participants

PRIMARY outcome

Timeframe: Week 104

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 are included.

Outcome measures

Outcome measures
Measure	Remitters n=34 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=103 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
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).	29 Participants	71 Participants	—	—

SECONDARY outcome

Timeframe: Week 152

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.

Outcome measures

Outcome measures
Measure	Remitters n=30 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=87 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 152 (Through 2 Years of Participation in NCT01070303).	26 Participants	62 Participants	—	—

SECONDARY outcome

Timeframe: Week 212

Population: Observed cases, that is, all participants who participating at Week 212 and had a CDAI measurement at that time point were included.

Outcome measures

Outcome measures
Measure	Remitters n=25 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=69 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 212 (Through 3 Years of Participation in NCT01070303).	21 Participants	45 Participants	—	—

SECONDARY outcome

Timeframe: Week 260

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 of Study NCT00055497 are included.

Outcome measures

Outcome measures
Measure	Remitters n=10 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=27 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Clinical Remission (CDAI < 150 Points) at Week 260 (4 Years of Participation in NCT01070303).	8 Participants	21 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 104

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 104 of Study NCT00055497 are included.

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.

Outcome measures

Outcome measures
Measure	Remitters n=34 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=103 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)	28 Participants	87 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 152

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 152 are included.

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.

Outcome measures

Outcome measures
Measure	Remitters n=30 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=87 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)	28 Participants	74 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 212

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 212

Outcome measures

Outcome measures
Measure	Remitters n=25 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=69 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)	23 Participants	58 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 260

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.

Outcome measures

Outcome measures
Measure	Remitters n=10 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=27 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)	8 Participants	27 Participants	—	—

SECONDARY outcome

Timeframe: Week 104

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at 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.

Outcome measures

Outcome measures
Measure	Remitters n=34 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=103 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-70 at Week 104 (1 Year of Participation in NCT01070303)	31 Participants	92 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in Study to Week 152

Population: The analysis population is observed cases, that is, all participants who CDAI evaluation at Week 152 are included.

Outcome measures

Outcome measures
Measure	Remitters n=30 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=87 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)	30 Participants	77 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 212

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation Week 212 are included.

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.

Outcome measures

Outcome measures
Measure	Remitters n=25 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=69 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)	24 Participants	63 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 260

Population: The analysis population is observed cases, that is, all participants who had CDAI evaluation at Week 260 are included.

Outcome measures

Outcome measures
Measure	Remitters n=10 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=27 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)	10 Participants	27 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 104

Population: The analysis population was observed cases, that is, all participants who were taking systemic corticosteroids at Baseline of NCT00055523 and who had CDAI evaluation and documentation of concomitant corticosteroid use (yes or no) at 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.

Outcome measures

Outcome measures
Measure	Remitters n=18 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=31 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)	8 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 152

Outcome measures

Outcome measures
Measure	Remitters n=18 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=30 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)	8 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 212

Outcome measures

Outcome measures
Measure	Remitters n=14 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=23 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)	5 Participants	10 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 260

Outcome measures

Outcome measures
Measure	Remitters n=6 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=12 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)	2 Participants	4 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Remitters n=18 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=31 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)	9 Participants	15 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 152

Outcome measures

Outcome measures
Measure	Remitters n=18 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=30 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)	9 Participants	15 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 212

Outcome measures

Outcome measures
Measure	Remitters n=14 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=23 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)	6 Participants	12 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 260

Outcome measures

Outcome measures
Measure	Remitters n=6 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=12 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)	2 Participants	5 Participants	—	—

SECONDARY outcome

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

Population: The analysis population is observed cases, that is, all participants who had an IBDQ score at the visit time point.

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.

Outcome measures

Outcome measures
Measure	Remitters n=142 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=114 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 n=99 Participants The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 n=69 Participants The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores	42.4 Scores on a scale Standard Deviation 36.27	47.9 Scores on a scale Standard Deviation 33.70	51.0 Scores on a scale Standard Deviation 32.77	51.7 Scores on a scale Standard Deviation 32.67

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 104

Population: The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at 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.

Outcome measures

Outcome measures
Measure	Remitters n=3 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=15 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)	1 Participants	11 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 152

Population: The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 152.

Outcome measures

Outcome measures
Measure	Remitters n=3 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=14 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)	2 Participants	11 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 212

Population: The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 212.

Outcome measures

Outcome measures
Measure	Remitters n=3 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=11 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)	1 Participants	10 Participants	—	—

SECONDARY outcome

Timeframe: From Baseline of lead-in study to Week 260

Population: The analysis population was observed cases, that is, all participants who draining fistulas at Baseline of NCT00055523 and who had data on draining fistulas(yes or no) at Week 260.

Outcome measures

Outcome measures
Measure	Remitters n=2 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score \< 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.	Non-Remitters n=7 Participants Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.	Change From Baseline-Week 200 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.	Change From Baseline-Week 248 The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)	2 Participants	6 Participants	—	—

Adverse Events

Remitters

Serious events: 6 serious events

Other events: 50 other events

Deaths: 0 deaths

Non-Remitters

Serious events: 69 serious events

Other events: 207 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER