A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Abbott

Status and phase: Completed; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Biological: adalimumab; Biological: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647491

M02-575

Details and patient eligibility

About

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

Enrollment: 352 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

352 participants in 4 patient groups, including a placebo group

20 mg

Experimental group

Description:

20 mg adalimumab eow

Treatment:

Biological: adalimumab

Biological: adalimumab

Biological: adalimumab

40 mg

Experimental group

Description:

40 mg adalimumab eow

Treatment:

Biological: adalimumab

Biological: adalimumab

Biological: adalimumab

80 mg

Experimental group

Description:

80 mg adalimumab eow

Treatment:

Biological: adalimumab

Biological: adalimumab

Biological: adalimumab

Placebo

Placebo Comparator group

Description:

Placebo eow

Treatment:

Biological: placebo