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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014