Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis

AbbVie

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650156

M10-017

Details and patient eligibility

About

Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or Female ages 18 years and older.
• Mild RA.
• Body weight less than 100 kg.

Exclusion criteria

• Wheelchair-bound or bedridden.
• Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
• Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
• Prior treatment with any TNF antagonist, including adalimumab.
• Positive tuberculin PPD 5.
• Female subjects who are pregnant or breast-feeding.
• History of HIV or of being immuno-compromised.
• History of malignancy.
• Poorly controlled medical condition.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

40 mg adalimumab

Experimental group

Treatment:

Biological: adalimumab

Biological: adalimumab

80 mg Adalimumab

Experimental group

Treatment:

Biological: adalimumab

Biological: adalimumab