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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: adalimumab (Biological); adalimumab (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Laura Redden, MD, Study Director, Affiliation: Abbott


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

Clinical Details

Official title: A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab

Secondary outcome:

Adverse event profile

VAS assessments

Swollen and Tender Joint counts


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

Site Reference ID/Investigator# 7181, Shanghai 200001, China
Additional Information

Starting date: June 2007
Last updated: November 11, 2010

Page last updated: August 23, 2015

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