A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647491
• Other study ID #: M02-575
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 27, 2008
• Last updated: March 27, 2008
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: August 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits >10 swollen joints, >12 tender joints.

• Subjects must have failed prior treatment with one or more DMARDs.

• A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.

• Body weight less than or equal to 100 kg

Exclusion Criteria:

• A history of, or current, acute inflammatory joint disease of different origin from RA.

• Prior treatment with any TNF antagonist, including adalimumab.

• Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.

• Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
20 mg sc eow
• adalimumab
40 mg sc eow
• adalimumab
80 mg sc eow
• placebo
placebo sc eow

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Eisai Limited

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20		Week 24	No
Secondary	ACR20		Week12	No
Secondary	ACR50		Weeks 12 and 24	No
Secondary	ACR70		Weeks 12 and 24	No