A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease

NCT01958827 | Completed Phase 3 Results

• 2 other identifiers: M13-6872015-004121-13
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Keywords

Dose Escalation; Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved Clinical Response 50 (CR50; Crohn's Disease Activity Index [CDAI] Decrease ≥ 50 From Week 0) at Week 8

  CDAI is used to quantify the signs and symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Non-responder imputation (NRI) for missing CDAI observations was used.

  Week 8

Secondary Outcomes (12)

• Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Every 4 Weeks up to Week 52

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• 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

  Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• 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

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• 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

  Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

• C-reactive Protein (CRP): Mean Change From Baseline (Week 0) to Week 52

  Baseline (Week 0) and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Other Outcomes (2)

• Change in Mean Serum Adalimumab Concentration From Baseline (Week 0) to Week 52

  Baseline (Week 0) to Week 52

• Change in Number of Subjects Positive for Anti-Adalimumab Antibodies (AAA) From Baseline to Week 52

  Baseline (Week 0) to Week 52

Study Arms (1)

Adalimumab 80 mg

EXPERIMENTAL

All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection.

Also known as: Humira, ABT-D2E7

Adalimumab 80 mg

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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.

  PMID: 30221150 DERIVED

Related Links

• Related Info.

MeSH Terms

Conditions

Crohn Disease

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Morio Ozawa, MS

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 9, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 12, 2016
• Results First Posted: April 12, 2016

Record last verified: 2016-03