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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Flu Rheumatoid Arthritis

Drug Information available for: Adalimumab Pneumococcal Vaccines

U.S. FDA Resources

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

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:	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 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Vaccines with adalimumab dosing

Additional relevant MeSH terms:

Anti-Inflammatory Agents
RNA Virus Infections
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Orthomyxoviridae Infections
Adalimumab
Pharmacologic Actions

Virus Diseases
Respiratory Tract Diseases
Musculoskeletal Diseases
Respiratory Tract Infections
Therapeutic Uses
Arthritis
Influenza, Human
Connective Tissue Diseases
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009