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.
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 |
Verified date | September 2010 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
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. |
Country | Name | City | State |
---|---|---|---|
China | Site Reference ID/Investigator# 7181 | Shanghai |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
China,
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
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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