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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00649922

Enrollment

226

Registered

2008-04-01

Start date

2003-10-31

Completion date

2005-02-28

Last updated

2008-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Vaccines with adalimumab dosing

Brief summary

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

Interventions

BIOLOGICALadalimumab

80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29

BIOLOGICALplacebo

2 injections Day 1, 1 injection Days 15 and 29

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Blood samples for Influenza A & B antibody Assay	Baseline (Day 1), Day 36 or premature discontinuation
Blood Samples for Pneumococcal Antibody Assay	Baseline (Day 1), Day 36 or premature discontinuation

Secondary

Measure	Time frame
Laboratory assessments	Screening, Week 15, Day 36, Month 3 and Month 6
Vitals signs	Screening - Month 6
Adverse events	Screening - Month 6

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026