Back to resultsPharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
adalimumab
adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
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.
Sites / Locations
- Site Reference ID/Investigator# 7181
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
40 mg adalimumab
80 mg Adalimumab
Arm Description
Outcomes
Primary Outcome Measures
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
Secondary Outcome Measures
Adverse event profile
VAS assessments
Swollen and Tender Joint counts
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00650156
Brief Title
Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
Official Title
A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AbbVie
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
40 mg adalimumab
Arm Type
Experimental
Arm Title
80 mg Adalimumab
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
40 mg single sc dose
Intervention Type
Biological
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
80 mg single sc dose
Primary Outcome Measure Information:
Title
pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
Time Frame
Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
Secondary Outcome Measure Information:
Title
Adverse event profile
Time Frame
follow up to day 70 after dose
Title
VAS assessments
Time Frame
Days 1, 15 and 29
Title
Swollen and Tender Joint counts
Time Frame
Days 1, 15 and 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Redden, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 7181
City
Shanghai
ZIP/Postal Code
200001
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
27338778
Citation
Burmester GR, Landewe 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.
Results Reference
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Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
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