Adalimumab Administered in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Injections in Korean Rheumatoid Arthritis Subjects Treated With Methotrexate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00235859
• Other study ID #: M02-556
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: August 28, 2007
• Start date: July 2003

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and efficacy of adalimumab compared to placebo in subjects with rheumatoid arthritis on methotrexate therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Meet ACR criteria for diagnosis of active RA and have at >6 swollen joints and >9 tender joints

• Subjects must have received at least one prior DMARD besides MTX, but may have had efficacy failures on no more than four standard DMARDs other than MTX

• Therapy with MTX for at least 6 months prior to screening and on a stable dose of MTX for at least 4 weeks prior to screening visit

• Age 18 years and older

Exclusion Criteria:

• Prior treatment with any TNF antagonist, including adalimumab

• History of clinically significant drug or alcohol abuse in the previous year, iv drug abuse, active infection with listeria or tuberculosis (TB), lymphoma or leukemia,and any malignancy with the exception of successfully treated non-metastatic basal-cell carcinoma of the skin.

• Subjects may not have been administered a live vaccine within three months prior to study drug administration or during the study, treatment with any other investigational agent within 30 days or 5 half-lives of the agent, whichever is longer, prior to the screening evaluation, treatment with any investigational biologic agent, including anti-CD4 antibody, within 6 months prior to the screening evaluation, prior treatment with any TNF antagonist, including Adalimumab, prior exposure to alkylating agents such as chlorambucil or cyclophosphamide.

• Chest X-ray with calcified granuloma and/or pleural scarring

• Positive TB skin test, RT23 dose skin test, >5 mm at 48 to 72 hours

• Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months of the screening evaluation) or any poorly controlled medical condition

• Intra-articular, intramuscular or iv administration of corticosteroids within 4 weeks prior to screening evaluation

• Female who is pregnant or breast-feeding.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• adalimumab

• methotrexate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Eisai Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20
Secondary	Safety parameters