Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00650156

Purpose

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

Condition	Intervention	Phase
Rheumatoid Arthritis	Biological: adalimumab	Phase I

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment
Official Title:	A Randomized, Parallel-Group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.

Further study details as provided by Abbott:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse event profile [ Time Frame: follow up to day 70 after dose ] [ Designated as safety issue: No ]
VAS assessments [ Time Frame: Days 1, 15 and 29 ] [ Designated as safety issue: No ]
Swollen and Tender Joint counts [ Time Frame: Days 1, 15 and 29 ] [ Designated as safety issue: No ]

Enrollment:	24
Study Start Date:	June 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
40 mg adalimumab: Experimental	Biological: adalimumab 40 mg single sc dose
80 mg Adalimumab: Experimental	Biological: adalimumab 80 mg single sc dose

Eligibility

Criteria

Inclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650156

Locations

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Michael Snyder, Clinical Research Manager )
Study ID Numbers:	M10-017
Study First Received:	March 28, 2008
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00650156 History of Changes
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antirheumatic Agents
Adalimumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Pharmacologic Actions
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009