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
• 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
• 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. 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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

External Links

•   clinical study report synopsis