A Study of Adalimumab in Japanese Subjects With Active Ankylosing Spondylitis

NCT00667355 | Completed Phase 3 Results

• 1 other identifier: M10-239
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 19

Brief Summary

To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with active ankylosing spondylitis

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20) at Week 12

  ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.

  Week 12

Secondary Outcomes (18)

• Number of Subjects Achieving ASAS 20

  Weeks 12, 24, 48, 72, 96, 120, and Final Visit

• Number of Subjects Achieving ASAS 50

  Weeks 12, 24, 48, 72, 96, 120, and Final Visit

• Number of Subjects Achieving ASAS 70

  Weeks 12, 24, 48, 72, 96, 120, and Final Visit

• Number of Subjects Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI 50)

  Weeks 12, 24, 48, 72, 96, 120, and Final Visit

• Mean Change From Baseline in Patient's Global Assessment of Disease Activity

  Baseline, Weeks 12, 24, 48, 72, 96, 120, and Final Visit

Study Arms (1)

Adalimumab

EXPERIMENTAL

Adalimumab 40 mg or 80 mg subcutaneously (SC) administered every other week (eow) until approval of adalimumab for Ankylosing Spondylitis (AS) in Japan. All subjects received 40 mg of adalimumab SC eow at Baseline. The subjects who completed 16 weeks of therapy and who failed to achieve Assessments in Ankylosing Spondylitis 20 (ASAS 20) response on or after Week 16, could increase the dose of adalimumab to 80 mg eow. When the dose was increased, the higher dose was to be continued during the rest of the study.

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

40 mg or 80 mg every other week, subcutaneous

Also known as: ABT-D2E7, Humira

Adalimumab

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 who meets the definition of Ankylosing Spondylitis based on the Modified New York Criteria, has a diagnosis of active Ankylosing Spondylitis and has had an inadequate response to or intolerance to one or more nonsteroidal anti-inflammatory drugs

You may not qualify if:

• History of cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
• Previously received anti-TNF therapy
• Spinal surgery or joint surgery involving joints to be assessed within 2 months prior to the Screening

Sponsors & Collaborators

• Abbott: lead
• Eisai Co., Ltd.: collaborator

Study Sites (19)

Site Reference # / Investigator 46791

Aichi, Japan

Location

Site Reference # / Investigator 46789

Fukui, Japan

Location

Site Reference # / Investigator 46798

Fukuoka, Japan

Location

Site Reference # / Investigator 46799

Fukuoka, Japan

Location

Site Reference # / Investigator 46796

Hiroshima, Japan

Location

Site Reference # / Investigator 46782

Hokkaido, Japan

Location

Site Reference # / Investigator 7297

Hokkaido, Japan

Location

Site Reference # / Investigator 46795

Hyōgo, Japan

Location

Site Reference # / Investigator 46797

Kagawa, Japan

Location

Site Reference # / Investigator 46787

Kanagawa, Japan

Location

Site Reference # / Investigator 46790

Nagano, Japan

Location

Site Reference # / Investigator 46793

Osaka, Japan

Location

Site Reference # / Investigator 46794

Osaka, Japan

Location

Site Reference # / Investigator 46783

Saitama, Japan

Location

Site Reference # / Investigator 46784

Saitama, Japan

Location

Site Reference # / Investigator 46792

Shiga, Japan

Location

Site Reference # / Investigator 46785

Tokyo, Japan

Location

Site Reference # / Investigator 46786

Tokyo, Japan

Location

Site Reference # / Investigator 46788

Toyama, Japan

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

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 Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Hideyuki Hashiba, BS

  Abbott

  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: April 24, 2008
• First Posted: April 28, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: January 1, 2011
• Last Updated: January 26, 2012
• Results First Posted: August 11, 2010

Record last verified: 2012-01

Locations

JP (19)