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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00650156
First received: March 28, 2008
Last updated: November 11, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
 Biological: adalimumab
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

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
Experimental: 40 mg adalimumab Biological: adalimumab
40 mg single sc dose
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Experimental: 80 mg Adalimumab Biological: adalimumab
80 mg single sc dose
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00650156

Locations
China
Site Reference ID/Investigator# 7181
Shanghai, China, 200001
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Redden, MD Abbott
  More Information

No publications provided

Responsible Party: Beverly Paperiello, Abbott
ClinicalTrials.gov Identifier: NCT00650156     History of Changes
Other Study ID Numbers: M10-017
Study First Received: March 28, 2008
Last Updated: November 11, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013