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

This study has been completed.
Information provided by:
Abbott Identifier:
First received: March 28, 2008
Last updated: November 11, 2010
Last verified: September 2010
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 ]

Secondary Outcome Measures:
  • Adverse event profile [ Time Frame: follow up to day 70 after dose ]
  • VAS assessments [ Time Frame: Days 1, 15 and 29 ]
  • Swollen and Tender Joint counts [ Time Frame: Days 1, 15 and 29 ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00650156

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Beverly Paperiello, Abbott Identifier: NCT00650156     History of Changes
Other Study ID Numbers: M10-017
Study First Received: March 28, 2008
Last Updated: November 11, 2010

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on June 23, 2017