Clinical trial NCT01958827: A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease
Official title: A Multicenter Open-label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Investigate Efficacy, Safety and Pharmacokinetics After Dose Escalation in Japanese Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Keywords: Dose Escalation
Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 28
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy, safety and pharmacokinetics after dose escalation in Japanese subjects with Crohn's Disease.

Detailed description: Subjects who are confirmed to meet all of the inclusion criteria and none of the exclusion criteria during screening period (≤ 21 days) will be given subcutaneous injections of open-label adalimumab 80 mg eow from Week 0 to Week 50. If a subject has an inadequate response at or after Week 8, the subject may be withdrawn from the study. Self-injection of study drug is permitted for the subjects who are willing to perform self-injection, if the investigator decided as appropriate. Disease activity will be evaluated by Crohn's disease activity index (CDAI) at Screening, Week 0 and every 4 weeks until Week 52. Follow-up will be performed at 70 days after the last dose of study drug by visit or telephone.

Eligibility criteria: Inclusion Criteria:

* Subject ≥ 15 years of age at the time of informed consent.
* Subject with Crohn's disease who received induction treatment of commercially available Humira® (160 mg initially and 80 mg at 2 weeks after initial dose), achieved response after initial dose, and then lost response during maintenance treatment with Humira®.
* Subject with elevated C-reactive Protein (CRP) at Screening.
* If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after the last dose of study drug.
* Subject has a negative tuberculosis (TB) screening assessment. If the subject has evidence of a latent TB infection; the subject must initiate and complete a minimum of 21 days of an ongoing TB prophylaxis (in such case, screening period can be prolonged until 21 days past after initiation of prophylaxis and study drug is administered) or have documented completion of a full course of TB prophylaxis, prior to Week 0.

Exclusion Criteria:

* Subject with suspicion of colitis other than Crohn's disease.
* Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
* Subject with abscess or suspicion of abscess, or subject with infection(s).

Primary outcomes:
measure: Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) Every 4 Weeks up to Week 52
timeFrame: Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Who Achieved Clinical Response 70 (CR70; Crohn's Disease Activity Index [CDAI] Decrease ≥ 70 From Week 0) Every 4 Weeks up to Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Percentage of Participants Who Achieved Clinical Response 100 (CR100; Crohn's Disease Activity Index [CDAI] Decrease of 100 From Week 0) Every 4 Weeks up to Week 52
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52
timeFrame: Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Number of Participants With Potentially Significant Hematology Parameters
timeFrame: 52 weeks
measure: Number of Participants With Potentially Significant Clinical Chemistry Parameters
timeFrame: 52 weeks
measure: Systolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Diastolic Blood Pressure: Mean Change From Baseline (Week 0) to Each Visit
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Heart Rate: Mean Change From Baseline (Week 0) to Each Visit
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Body Temperature: Mean Change From Baseline (Week 0) to Each Visit
timeFrame: Baseline (Week 0) and Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 60 weeks
Other outcomes:
measure: Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52
timeFrame: Baseline (Week 0) to Week 52
measure: Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52
timeFrame: Baseline (Week 0) to Week 52
Locations:
Study officials:
affiliation: AbbVie
name: Morio Ozawa, MS
role: STUDY_DIRECTOR
References:
citation: Motoya S, Watanabe M, Wallace K, Lazar A, Nishimura Y, Ozawa M, Thakkar R, Robinson AM, Singh RSP, Mostafa NM, Suzuki Y, Hibi T. Efficacy and Safety of Dose Escalation to Adalimumab 80 mg Every Other Week in Japanese Patients with Crohn's Disease Who Lost Response to Maintenance Therapy. Inflamm Intest Dis. 2018 Jul;2(4):228-235. doi: 10.1159/000486786. Epub 2018 May 15.