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

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00649922

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 IV

MedlinePlus related topics: Flu Rheumatoid Arthritis

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

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
Double Blind: Placebo Comparator	Biological: adalimumab 80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29 Biological: placebo 2 injections Day 1, 1 injection Days 15 and 29
Open Label: Experimental	Biological: adalimumab 40 mg adalimumab every other week

Eligibility

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

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

Keywords provided by Abbott:

Vaccines with adalimumab dosing

Study placed in the following topic categories:

Virus Diseases
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Influenza, Human
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 January 15, 2009