Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00649922
First received: March 28, 2008
Last updated: March 31, 2008
Last verified: March 2008
  Purpose

To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo


Condition Intervention Phase
Rheumatoid Arthritis
Biological: adalimumab
Biological: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Blood samples for Influenza A & B antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ] [ Designated as safety issue: No ]
  • Blood Samples for Pneumococcal Antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory assessments [ Time Frame: Screening, Week 15, Day 36, Month 3 and Month 6 ] [ Designated as safety issue: No ]
  • Vitals signs [ Time Frame: Screening - Month 6 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Screening - Month 6 ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: October 2003
Study Completion Date: February 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Double Blind Biological: adalimumab
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Biological: placebo
2 injections Day 1, 1 injection Days 15 and 29
Other Name: placebo
Experimental: Open Label Biological: adalimumab
40 mg adalimumab every other week
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab

  Eligibility

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

Inclusion Criteria:

  • Male/Females at least 20 years of age.
  • Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
  • Females have a negative pregnancy test at screening.
  • Diagnosis of RA and met ACR criteria.
  • Must discontinue any TNF at least 2 months prior to baseline.
  • In condition of general good health.

Exclusion Criteria:

  • History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
  • History of current acute inflammatory joint disease.
  • Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
  • Recent (3 month) history of influenza or pneumococcal bacterial infection.
  • Known positive human immunodeficiency virus (HIV) status.
  • Positive hepatitis B or hepatitis C virus.
  • Positive PPD >5 mm.
  • Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lawrence McNamee, Sr. Clinical Research Manager, Abbott
ClinicalTrials.gov Identifier: NCT00649922     History of Changes
Other Study ID Numbers: M03-600
Study First Received: March 28, 2008
Last Updated: March 31, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Vaccines with adalimumab dosing

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
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 22, 2014