Remission in Subjects With Crohn's Disease, Open Label Ex... | NCT01070303

Label	Type	Description	Intervention Names
Adalimumab 40 mg every other week or every week	Experimental		Biological: Adalimumab 40 mg eow or ew

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab 40 mg eow or ew	Biological	Adalimumab 40 mg by subcutaneous injection every other week or every week	Adalimumab 40 mg every other week or every week

Measure	Description	Time Frame
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).	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.	Week 104

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

Name	Affiliation	Role
Anne Camez, MD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Associates of the East Bay		Berkeley	California	94705	United States
Long Beach Gastroenterology Assoc.

PubMed Identifier	Type	Citation	Retractions
29380251	Derived	Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6.

ID	Title	Description
FG000	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).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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).

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.

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

Posted

Number

Participants

Week 104

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Units	Counts
Participants	OG00034 OG001103

Title

Denominators

Categories

Title	Measurements
	OG00029 OG00171

Secondary

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

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

Posted

Number

Participants

Week 152

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Units	Counts

Secondary

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

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

Posted

Number

Participants

Week 212

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Units	Counts

Secondary

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

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

Posted

Number

Participants

Week 260

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Units	Counts

Secondary

Number of Participants Achieving CR-100 at Week 104 (1 Year of Participation in NCT01070303)

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.

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

Posted

Number

Participants

From Baseline of lead-in study to Week 104

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving CR-100 at Week 152 (2 Years of Participation in NCT01070303)

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.

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

Posted

Number

Participants

From Baseline of lead-in study to Week 152

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving CR-100 at Week 212 (3 Years of Participation in NCT01070303)

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

Posted

Number

Participants

From Baseline of lead-in study to Week 212

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving CR-100 at Week 260 (4 Years of Participation in NCT01070303)

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

Posted

Number

Participants

From Baseline of lead-in study to Week 260

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

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

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.

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

Posted

Number

Participants

Week 104

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving CR-70 at Week 152 (2 Years of Participation in NCT01070303)

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

Posted

Number

Participants

From Baseline of lead-in Study to Week 152

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving CR-70 at Week 212 (3 Years of Participation in NCT01070303)

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.

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

Posted

Number

Participants

From Baseline of lead-in study to Week 212

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving CR-70 at Week 260 (4 Years of Participation in NCT01070303)

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

Posted

Number

Participants

From Baseline of lead-in study to Week 260

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free Clinical Remission at Week 104 (1 Year of Participation in NCT01070303)

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.

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.

Posted

Number

Participants

From Baseline of lead-in study to Week 104

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Achieving Steroid-free Clinical Remission at Week 152 (2 Years of Participation in NCT01070303)

Posted

Number

Participants

From Baseline of lead-in study to Week 152

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free Clinical Remission at Week 212 (3 Years of Participation in NCT01070303)

Posted

Number

Participants

From Baseline of lead-in study to Week 212

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free Clinical Remission at Week 260 (4 Years of Participation in NCT01070303)

Posted

Number

Participants

From Baseline of lead-in study to Week 260

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free CR-100 at Week 104 (1 Year of Participation in NCT01070303)

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.

Posted

Number

Participants

From Baseline of lead-in study to Week 104

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free CR-100 at Week 152 (2 Years of Participation in NCT01070303)

Posted

Number

Participants

From Baseline of lead-in study to Week 152

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free CR-100 at Week 212 (3 Years of Participation in NCT01070303)

Posted

Number

Participants

From Baseline of lead-in study to Week 212

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Steroid-free CR-100 at Week 260 (4 Years of Participation in NCT01070303)

Posted

Number

Participants

From Baseline of lead-in study to Week 260

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores

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.

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

Posted

Mean

Standard Deviation

Scores on a scale

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

ID	Title	Description
OG000	Change From Baseline-Week 104	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.
OG001	Change From Baseline-Week 152	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.

Secondary

Number of Participants Achieving Fistula Remission at Week 104 (1 Year of Participation in NCT01070303)

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.

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.

Posted

Number

Participants

From Baseline of lead-in study to Week 104

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Fistula Remission at Week 152 (2 Years of Participation in NCT01070303)

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.

Posted

Number

Participants

From Baseline of lead-in study to Week 152

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Fistula Remission at Week 212 (3 Years of Participation in NCT01070303)

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.

Posted

Number

Participants

From Baseline of lead-in study to Week 212

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Secondary

Number of Participants Achieving Fistula Remission at Week 260 (Years of Participation in NCT01070303)

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.

Posted

Number

Participants

From Baseline of lead-in study to Week 260

ID	Title	Description
OG000	Remitters	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.
OG001	Non-Remitters	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Coronary artery disease	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0011 affected221 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Colonic stenosis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0011 affected221 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0010 affected221 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG00117 affected221 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Gastritis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Ileal stenosis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0013 affected221 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0011 affected221 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0018 affected221 at risk
Small intestinal stenosis	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0013 affected221 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Fatigue	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Non-cardiac chest pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Pyrexia	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Sphincter of Oddi dysfunction	Hepatobiliary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Abdominal abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Abscess intestinal	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Anal abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Appendicitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Diverticulitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Folliculitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Lobar pneumonia	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Meningitis viral	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Nocardiosis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Parvovirus infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Pneumonia	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0010 affected221 at risk
Pyelonephritis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Rectal abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Retroperitoneal abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Sepsis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Septic shock	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0010 affected221 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Langerhans' cell granulomatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Headache	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Optic neuritis	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0012 affected221 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG0010 affected221 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk
Haemorrhage	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG0011 affected221 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00111 affected221 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0015 affected221 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00123 affected221 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG00012 affected55 at risk EG00142 affected221 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00110 affected221 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00123 affected221 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG00117 affected221 at risk
Constipation	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00117 affected221 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG00023 affected55 at risk EG00170 affected221 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00136 affected221 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG00123 affected221 at risk
Flatulence	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00117 affected221 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00122 affected221 at risk
Nausea	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00151 affected221 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00119 affected221 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0010 affected221 at risk
Vomiting	Gastrointestinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG00128 affected221 at risk
Chest pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00114 affected221 at risk
Fatigue	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0006 affected55 at risk EG00126 affected221 at risk
Influenza like illness	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00118 affected221 at risk
Injection site irritation	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0009 affected55 at risk EG00121 affected221 at risk
Injection site pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00112 affected221 at risk
Injection site reaction	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00122 affected221 at risk
Pain	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG00112 affected221 at risk
Pyrexia	General disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00133 affected221 at risk
Seasonal allergy	Immune system disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0012 affected221 at risk
Bronchitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00115 affected221 at risk
Fungal infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG00112 affected221 at risk
Gastroenteritis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG00113 affected221 at risk
Influenza	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00128 affected221 at risk
Nasopharyngitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG00015 affected55 at risk EG00150 affected221 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0014 affected221 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0013 affected221 at risk
Sinusitis	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0006 affected55 at risk EG00134 affected221 at risk
Tooth abscess	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0018 affected221 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00130 affected221 at risk
Urinary tract infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG00124 affected221 at risk
Viral infection	Infections and infestations	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00112 affected221 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0015 affected221 at risk
Antinuclear antibody positive	Investigations	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0014 affected221 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG00112 affected221 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00143 affected221 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG00131 affected221 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG00113 affected221 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0011 affected221 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00113 affected221 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00112 affected221 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0000 affected55 at risk EG00119 affected221 at risk
Dizziness	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00112 affected221 at risk
Headache	Nervous system disorders	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00147 affected221 at risk
Anxiety	Psychiatric disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00113 affected221 at risk
Depression	Psychiatric disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG00116 affected221 at risk
Insomnia	Psychiatric disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG00126 affected221 at risk
Haematuria	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00110 affected221 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00113 affected221 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00117 affected221 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG0015 affected221 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00117 affected221 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00112 affected221 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG0016 affected221 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0002 affected55 at risk EG00112 affected221 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG00114 affected221 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0007 affected55 at risk EG0019 affected221 at risk
Pruritis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0005 affected55 at risk EG00110 affected221 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0017 affected221 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0008 affected55 at risk EG00132 affected221 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0004 affected55 at risk EG0014 affected221 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA 11.1	Non-systematic Assessment	EG0003 affected55 at risk EG0012 affected221 at risk
Hypertension	Vascular disorders	MedDRA 11.1	Non-systematic Assessment	EG0001 affected55 at risk EG00115 affected221 at risk

ID	Term
D003424	Crohn Disease
D015212	Inflammatory Bowel Diseases

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Remitters	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.
BG001	Non-Remitters	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Remitters	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.			6	55	50	55
EG001	Non-Remitters	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.			69	221	207	221