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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00649922
• Other study ID #: M03-600
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2008
• Last updated: March 31, 2008
• Start date: October 2003
• Est. completion date: February 2005

Study information

• Verified date: March 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: February 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
• placebo
2 injections Day 1, 1 injection Days 15 and 29
• adalimumab
40 mg adalimumab every other week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood samples for Influenza A & B antibody Assay		Baseline (Day 1), Day 36 or premature discontinuation	No
Primary	Blood Samples for Pneumococcal Antibody Assay		Baseline (Day 1), Day 36 or premature discontinuation	No
Secondary	Laboratory assessments		Screening, Week 15, Day 36, Month 3 and Month 6	No
Secondary	Vitals signs		Screening - Month 6	No
Secondary	Adverse events		Screening - Month 6	No