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NCT00650156 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00650156
Other study ID # M10-017
Secondary ID
Status Completed
Phase Phase 1
First received March 28, 2008
Last updated November 16, 2017
Start date June 2007

Study information
Verified date September 2010
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• adalimumab
40 mg single sc dose
• adalimumab
80 mg single sc dose

Locations
Country Name City State
China Site Reference ID/Investigator# 7181 Shanghai

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

China, 

References & Publications (1)

Burmester GR, Landewé R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
Secondary Adverse event profile follow up to day 70 after dose
Secondary VAS assessments Days 1, 15 and 29
Secondary Swollen and Tender Joint counts Days 1, 15 and 29
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