Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

NCT00235833 | Completed Phase 2 Results

• 1 other identifier: M02-564
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders)

  Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts \[TJC or SJC, respectively\] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity \[PGA\], \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of functional disability via a health assessment questionnaire \[HAQ\], and \[5\] C-reactive protein \[CRP\]) at each visit

  Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

Secondary Outcomes (9)

• Mean Change From Baseline in Tender Joint Count (TJC, Max = 68), a Component of the ACR Criteria, by Visit

  Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

• Mean Change From Baseline in Swollen Joint Count (SJC, Max = 66), a Component of the ACR Criteria, by Visit

  Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

• Mean Change From Baseline in Physician's Global Assessment of Disease Activity (PGA) Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit

  Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

• Mean Change From Baseline in Subject's Global Assessment of Disease Activity Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Assessment), a Component of the ACR Criteria, by Visit

  Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

• Mean Change From Baseline (Last Assessment in Preceding Study Prior to Adalimumab Injection) in Subject's Assessment of Pain Using a Visual Analog Scale (0 - 100 mm With 100 mm Being the Worst Possible Pain), a Component of the ACR Criteria, by Visit

  Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value)

Study Arms (1)

Adalimumab 40 mg eow

EXPERIMENTAL

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

40 mg every other week (eow), subcutaneous (sc)

Also known as: ABT-D2E7, Humira

Adalimumab 40 mg eow

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in the prior adalimumab study
• Body weight less than 100 kg.
• Subject's who wished to continue the study drug administration
• Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.

You may not qualify if:

• A subject who experienced any of the following during the prior adalimumab sc dosing study:
• Advanced or poorly controlled diabetes
• Any poorly controlled medical condition
• Intra-articular, intramuscular or iv administration of corticosteroids
• Joint surgery.
• A subject who has been prescribed excluded medications during previous adalimumab study.
• History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
• A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
• Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.

Sponsors & Collaborators

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

Study Sites (7)

Unknown Facility

Tokyo, Metropolis, Japan

Location

Unknown Facility

Fukuoka, Prefecture, Japan

Location

Unknown Facility

Hiroshima, Prefecture, Japan

Location

Unknown Facility

Ibaraki, Prefecture, Japan

Location

Unknown Facility

Nagasaki, Prefecture, Japan

Location

Unknown Facility

Osaka, Prefecture, Japan

Location

Unknown Facility

Saitama, Prefecture, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Due to the small population, statistical tests were not performed.

Results Point of Contact

• Title: Medical Information Specialist
• Organization: Abbott

800-633-9110

Study Officials

• Shigeki Hashimoto, Ph.D.

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: June 1, 2003
• Primary Completion: October 1, 2004
• Last Updated: April 11, 2011
• Results First Posted: January 29, 2010

Record last verified: 2011-04

Locations

JP (7)