Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
|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.|
|ClinicalTrials.gov Identifier: NCT00649922|
Recruitment Status : Completed
First Posted : April 1, 2008
Last Update Posted : April 1, 2008
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To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: adalimumab Biological: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||February 2005|
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics: Rheumatoid arthritis
MedlinePlus related topics: Arthritis Flu Flu Shot Rheumatoid Arthritis Vaccines
Drug Information available for: Adalimumab
|Placebo Comparator: Double Blind||
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
2 injections Day 1, 1 injection Days 15 and 29
|Experimental: Open Label||
40 mg adalimumab every other week
Primary Outcome Measures :
- Blood samples for Influenza A & B antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ]
- Blood Samples for Pneumococcal Antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ]
Secondary Outcome Measures :
- Laboratory assessments [ Time Frame: Screening, Week 15, Day 36, Month 3 and Month 6 ]
- Vitals signs [ Time Frame: Screening - Month 6 ]
- Adverse events [ Time Frame: Screening - Month 6 ]
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|Ages Eligible for Study:||20 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
|Responsible Party:||Lawrence McNamee, Sr. Clinical Research Manager, Abbott|
|Other Study ID Numbers:||
|First Posted:||April 1, 2008 Key Record Dates|
|Last Update Posted:||April 1, 2008|
|Last Verified:||March 2008|
Keywords provided by Abbott:
Vaccines with adalimumab dosing
Additional relevant MeSH terms:
Connective Tissue Diseases
Immune System Diseases