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Trial Outcomes & Findings for A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease (NCT NCT00445939)

NCT ID: NCT00445939

Last Updated: 2011-06-27

Results Overview

CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI \< 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

90 participants

Primary outcome timeframe

4 Weeks

Results posted on

2011-06-27

Participant Flow

Subjects with moderate to severe Crohn's Disease (Crohn's Disease Activity Index \[CDAI\] \>= 220 and \<= 450) were enrolled into study. The period from the first dose of study drug to the evaluation at Week 4 is Period A. The period from the study drug injection at Week 4 to the evaluation at Week 8 is Period B.

All subjects were evaluated at Week 4. If responders (CDAI decrease \>= 70 points compared to Baseline), rolled over to a maintenance study. If non-responders (CDAI decrease of \< 70 points compared to Baseline), continued in study and received: adalimumab 160/80 mg + 40/40 mg, or adalimumab 80/40 mg + 40/40 mg or placebo + adalimumab 160/80 mg.

Participant milestones

Participant milestones
Measure
Adalimumab 160 mg/80 mg
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
Placebo at Week 0, placebo at Week 2
Adalimumab 40mg /40 mg
Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
Period A - Week 0 - Week 4
STARTED
33
34
23
0
Period A - Week 0 - Week 4
COMPLETED
32
32
23
0
Period A - Week 0 - Week 4
NOT COMPLETED
1
2
0
0
Period B - Week 4 - Week 8
STARTED
16
0
0
21
Period B - Week 4 - Week 8
COMPLETED
14
0
0
20
Period B - Week 4 - Week 8
NOT COMPLETED
2
0
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Adalimumab 160 mg/80 mg
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
Placebo at Week 0, placebo at Week 2
Adalimumab 40mg /40 mg
Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
Period A - Week 0 - Week 4
Adverse Event
1
2
0
0
Period B - Week 4 - Week 8
Adverse Event
2
0
0
1

Baseline Characteristics

A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Adalimumab 160 mg/80 mg
n=33 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
n=34 Participants
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
n=23 Participants
Placebo at Week 0, placebo Week 2
Total
n=90 Participants
Total of all reporting groups
Age Continuous
32.0 years
STANDARD_DEVIATION 9.60 • n=5 Participants
30.6 years
STANDARD_DEVIATION 9.26 • n=7 Participants
30.4 years
STANDARD_DEVIATION 6.93 • n=5 Participants
31.1 years
STANDARD_DEVIATION 8.80 • n=4 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
18 Participants
n=7 Participants
7 Participants
n=5 Participants
38 Participants
n=4 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
16 Participants
n=7 Participants
16 Participants
n=5 Participants
52 Participants
n=4 Participants
Region of Enrollment
Japan
33 participants
n=5 Participants
34 participants
n=7 Participants
23 participants
n=5 Participants
90 participants
n=4 Participants

PRIMARY outcome

Timeframe: 4 Weeks

Population: The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations.

CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI \< 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.

Outcome measures

Outcome measures
Measure
Adalimumab 160 mg/80 mg
n=33 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
n=34 Participants
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
n=23 Participants
Placebo at Week 0, placebo at Week 2
The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4
11 Particpants
6 Particpants
3 Particpants

SECONDARY outcome

Timeframe: Week 2

Population: Subjects with a clinical remission (CDAI \<= 150) in the adalimumab 160 mg (Week 0/80 mg (Week 2) and adalimumab 80 mg (Week 0)/40 mg (Week 2) in full analysis set using Non-responder Imputation.

Number of subjects in each treatment group in clinical remission (CDAI \< 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2.

Outcome measures

Outcome measures
Measure
Adalimumab 160 mg/80 mg
n=33 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
n=34 Participants
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
n=23 Participants
Placebo at Week 0, placebo at Week 2
Clinical Remission (CDAI < 150) at Week 2
Week 2
6 Participants
5 Participants
1 Participants

SECONDARY outcome

Timeframe: Weeks 2 and Week 4

Population: The secondary efficacy analysis was performed using descriptive statistics in randomized subjects who received at least one dose of study drug (full analysis set) in the three treatment groups: Adalimumab 160 mg/80 mg, adalimumab 80mg/40 mg, and placebo.

The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of \>=70 compared to Baseline) and 100 (CDAI decrease of \>=100 compared to Baseline) at Week 2 and Week 4.

Outcome measures

Outcome measures
Measure
Adalimumab 160 mg/80 mg
n=33 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
n=34 Participants
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
n=23 Participants
Placebo at Week 0, placebo at Week 2
Clinical Response (CR-70 and CR-100) in Period A
CR-70 at Week 2
15 participants
17 participants
4 participants
Clinical Response (CR-70 and CR-100) in Period A
CR-70 at Week 4
23 participants
20 participants
7 participants
Clinical Response (CR-70 and CR-100) in Period A
CR-100 at Week 2
10 participants
11 participants
2 participants
Clinical Response (CR-70 and CR-100) in Period A
CR-100 at Week 4
15 participants
17 participants
4 participants

SECONDARY outcome

Timeframe: Week 6 and Week 8

Population: Full analysis set - subjects rated as non-responders (did not attain CDAI reduction \>= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg.

The Number of subjects in each treatment group with a CR-70 (CDAI decrease of \>= 70 compared to Baseline) and 100 (CDAI decrease of \>= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8.

Outcome measures

Outcome measures
Measure
Adalimumab 160 mg/80 mg
n=9 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
n=12 Participants
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
n=16 Participants
Placebo at Week 0, placebo at Week 2
Clinical Response (CR-70 and CR-100) in Period B
CR-100 at Week 6
0 Participants
1 Participants
3 Participants
Clinical Response (CR-70 and CR-100) in Period B
CR-100 at Week 8
0 Participants
2 Participants
7 Participants
Clinical Response (CR-70 and CR-100) in Period B
CR-70 at Week 6
1 Participants
4 Participants
9 Participants
Clinical Response (CR-70 and CR-100) in Period B
CR-70 at Week 8
3 Participants
5 Participants
12 Participants

SECONDARY outcome

Timeframe: Week 6 and Week 8

Population: Subjects who were rated as non-responders (CDAI reduction \< 70) in the evaluation of clinical remission (CDAI\<150) at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg.

The number of subjects with clinical remission (CDAI \< 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8

Outcome measures

Outcome measures
Measure
Adalimumab 160 mg/80 mg
n=33 Participants
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
n=34 Participants
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
n=23 Participants
Placebo at Week 0, placebo at Week 2
Clinical Remission (CDAI <150) at Week 6 and Week 8
Clinical Remission at Week 6
0 Participants
1 Participants
2 Participants
Clinical Remission (CDAI <150) at Week 6 and Week 8
Clinical Remission at Week 8
0 Participants
1 Participants
2 Participants

Adverse Events

Adaliumab 160 mg/80 mg

Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths

Adalimumab 80 mg/40 mg

Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths

Placebo

Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths

Adalimumab 160 mg/80 mg + 40/40 mg

Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths

80/40 mg + 40/40 mg

Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths

Placebo + Adalimumab 160/80 mg

Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Adaliumab 160 mg/80 mg
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
Placebo at Week 0, placebo at Week 2
Adalimumab 160 mg/80 mg + 40/40 mg
Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
80/40 mg + 40/40 mg
Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
Placebo + Adalimumab 160/80 mg
Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
Infections and infestations
Abdominal abcess
0.00%
0/33
2.9%
1/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Investigations
C-reactive protein increased (at investigator's discretion)
0.00%
0/33
2.9%
1/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Gastrointestinal disorders
Crohn's Disease
0.00%
0/33
5.9%
2/34
8.7%
2/23
11.1%
1/9
8.3%
1/12
0.00%
0/16
Reproductive system and breast disorders
Epididymitis
3.0%
1/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Gastrointestinal disorders
Subileus
0.00%
0/33
2.9%
1/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16

Other adverse events

Other adverse events
Measure
Adaliumab 160 mg/80 mg
Adalimumab 160 mg at Week 0, 80 mg at Week 2
Adalimumab 80 mg/40 mg
Adalimumab 80 mg at Week 0, 40 mg at Week 2
Placebo
Placebo at Week 0, placebo at Week 2
Adalimumab 160 mg/80 mg + 40/40 mg
Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
80/40 mg + 40/40 mg
Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
Placebo + Adalimumab 160/80 mg
Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
Gastrointestinal disorders
Abdominal distension
6.1%
2/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Gastrointestinal disorders
Abdominal pain
0.00%
0/33
0.00%
0/34
4.3%
1/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
General disorders
Adverse drug reaction
3.0%
1/33
2.9%
1/34
4.3%
1/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Blood and lymphatic system disorders
Anaemia
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Investigations
Antinuclear antibody increased (at investigator's discretion)
0.00%
0/33
2.9%
1/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
General disorders
Application site swelling
0.00%
0/33
0.00%
0/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
6.2%
1/16
Investigations
Blood albumin decreased (at investigator's discretion)
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Investigations
Blood creatine phosphokinase (at investigator's discretion)
0.00%
0/33
2.9%
1/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Investigations
Blood glucose increased (at investigator's discretion)
6.1%
2/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
General disorders
Chest pain
0.00%
0/33
0.00%
0/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Gastrointestinal disorders
Constipation
6.1%
2/33
0.00%
0/34
4.3%
1/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Gastrointestinal disorders
Diarrhoea
0.00%
0/33
0.00%
0/34
4.3%
1/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
6.2%
1/16
General disorders
Feeling abnormal
0.00%
0/33
0.00%
0/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Metabolism and nutrition disorders
Glucose tolerance impaired (at investigator's discretion)
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Gastrointestinal disorders
Haemorrhoids
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
6.2%
1/16
Nervous system disorders
Headache
9.1%
3/33
0.00%
0/34
4.3%
1/23
0.00%
0/9
16.7%
2/12
6.2%
1/16
Hepatobiliary disorders
Hepatic function abnormal
3.0%
1/33
5.9%
2/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Infections and infestations
Herpes Simplex
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
6.2%
1/16
Immune system disorders
Hypersensitivity
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/33
0.00%
0/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
General disorders
Injection site erythema
6.1%
2/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
General disorders
Injection site pain
3.0%
1/33
5.9%
2/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
General disorders
Injection site reaction
3.0%
1/33
8.8%
3/34
8.7%
2/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
General disorders
Instillation site pain
0.00%
0/33
0.00%
0/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Gastrointestinal disorders
Intestinal obstruction
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
6.2%
1/16
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/33
2.9%
1/34
0.00%
0/23
11.1%
1/9
0.00%
0/12
6.2%
1/16
General disorders
Malaise
0.00%
0/33
8.8%
3/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Infections and infestations
Nasopharyngitis
0.00%
0/33
2.9%
1/34
0.00%
0/23
11.1%
1/9
8.3%
1/12
18.8%
3/16
Gastrointestinal disorders
Nausea
3.0%
1/33
2.9%
1/34
13.0%
3/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
General disorders
Pyrexia
3.0%
1/33
5.9%
2/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Skin and subcutaneous tissue disorders
Rash
6.1%
2/33
0.00%
0/34
4.3%
1/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/33
8.8%
3/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
0.00%
0/16
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Infections and infestations
Tonsillitis
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
8.3%
1/12
0.00%
0/16
Infections and infestations
Upper respiratory tract infection
9.1%
3/33
2.9%
1/34
4.3%
1/23
11.1%
1/9
0.00%
0/12
0.00%
0/16
Infections and infestations
Urinary tract infection
0.00%
0/33
0.00%
0/34
0.00%
0/23
0.00%
0/9
0.00%
0/12
6.2%
1/16
Gastrointestinal disorders
Vomiting
6.1%
2/33
0.00%
0/34
4.3%
1/23
0.00%
0/9
0.00%
0/12
0.00%
0/16

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

  • Principal investigator is a sponsor employee Disclosure agreements vary; most restrictive agreement states Medical Institution shall not disclose materials/information disclosed by Abbott Japan in connection with the Clinical Research, or information obtained by conducting the Clinical Research, to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting the Clinical Research, Medical Institution shall obtain Abbott Japan's prior written approval.
  • Publication restrictions are in place

Restriction type: OTHER