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Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Abbott
Abbott Japan Co.,Ltd
Eisai Limited
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00235833
  Purpose

The purpose of the study is to assess the long-term safety and tolerability of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.


Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Phase II

MedlinePlus related topics:   Rheumatoid Arthritis   

ChemIDplus related topics:   Adalimumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:   Long-Term Continuously Repeated Dose Study of Adalimumab (D2E7) in Patients With Rheumatoid Arthritis

Further study details as provided by Abbott:

Primary Outcome Measures:
  • A comparison of adverse events [ Time Frame: Every 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACR 20/50/70 [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Patient reported outcomes [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]
  • Physician Global Assessment [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ]

Enrollment:   25
Study Start Date:   June 2003
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Adalimumab 40 mg eow: Experimental Biological: adalimumab
40 mg eow, sc

  Eligibility
Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Participation in the prior adalimumab study
  • Body weight less than 100 kg.
  • Females must be postmenopausal for at least 1 year, surgically sterile, or practicing birth control throughout the study and for 90 days after study completion.

Exclusion Criteria:

  • A subject who experienced any of the following during the prior adalimumab sc dosing study:

    • Advanced or poorly controlled diabetes
    • Any poorly controlled medical condition
    • Intra-articular, intramuscular or iv administration of corticosteroids
    • Joint surgery.
  • A subject who has been prescribed excluded medications during previous adalimumab study.
  • History of clinically significant drug or alcohol abuse, intravenous (iv) drug abuse, active infection with listeria or tuberculosis (TB), lymphoma, leukemia, or any malignancy with the exception of successfully treated non- metastatic basal cell carcinoma of the skin.
  • A subject who experienced chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous (iv) antibiotics within 30 days of entry into study or chronic use of oral antibiotics within 14 days of entry into study.
  • Preexisting or recent onset of central nervous system (CNS) demyelinating disorders.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235833

Locations
Japan, Metropolis
      Tokyo, Metropolis, Japan
Japan, Prefecture
      Ibaraki, Prefecture, Japan
      Saitama, Prefecture, Japan
      Nagasaki, Prefecture, Japan
      Hiroshima, Prefecture, Japan
      Fukuoka, Prefecture, Japan
      Osaka, Prefecture, Japan

Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Eisai Limited

Investigators
Study Director:     Shigeki Hashimoto, Ph.D.     Abbott    
  More Information


Responsible Party:   Abbott ( Eiichi Makino )
Study ID Numbers:   M02-564
First Received:   October 7, 2005
Last Updated:   August 13, 2008
ClinicalTrials.gov Identifier:   NCT00235833
Health Authority:   Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Rheumatoid Arthritis  

Study placed in the following topic categories:
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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