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:
Abbott
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00649922
First received: March 28, 2008
Last updated: March 31, 2008
Last verified: March 2008
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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:
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:
|
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
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 Influenza, Human Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Orthomyxoviridae Infections |
RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013