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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00650156
First Posted: April 1, 2008
Last Update Posted: November 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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: None (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00650156


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beverly Paperiello, Abbott
ClinicalTrials.gov Identifier: NCT00650156     History of Changes
Other Study ID Numbers: M10-017
First Submitted: March 28, 2008
First Posted: April 1, 2008
Last Update Posted: November 15, 2010
Last Verified: September 2010

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