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

March 31, 2008 updated by: Abbott
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label
Biological: adalimumab
40 mg adalimumab every other week
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
Other Names:
  • ABT-D2E7
  • Humira
Placebo Comparator: Double Blind
Biological: adalimumab
40 mg adalimumab every other week
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
Other Names:
  • ABT-D2E7
  • Humira
Biological: placebo
2 injections Day 1, 1 injection Days 15 and 29

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

February 1, 2005

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

April 1, 2008

Last Update Submitted That Met QC Criteria

March 31, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-600

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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