A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00647491
• Date of registration: 27/03/2008
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
• Date of first enrolment: February 2004
• Target sample size: 352
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00647491
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Japan

Contacts

• Name: Shigeki Hashimoto, Ph.D.
• Affiliation: Abbott

Key inclusion & exclusion criteria

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.



Age minimum: 20 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: adalimumab

Biological: placebo

Primary Outcome(s)

ACR20 [Time Frame: Week 24]

Secondary Outcome(s)

ACR70 [Time Frame: Weeks 12 and 24]

ACR50 [Time Frame: Weeks 12 and 24]

ACR20 [Time Frame: Week12]

Secondary ID(s)

M02-575

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eisai Limited