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

NCT ID: NCT00649922

Last Updated: 2008-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-02-28

Brief Summary

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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Keywords

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Vaccines with adalimumab dosing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Double Blind

Group Type PLACEBO_COMPARATOR

adalimumab

Intervention Type BIOLOGICAL

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

placebo

Intervention Type BIOLOGICAL

2 injections Day 1, 1 injection Days 15 and 29

Open Label

Group Type EXPERIMENTAL

adalimumab

Intervention Type BIOLOGICAL

40 mg adalimumab every other week

Interventions

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adalimumab

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

Intervention Type BIOLOGICAL

placebo

2 injections Day 1, 1 injection Days 15 and 29

Intervention Type BIOLOGICAL

adalimumab

40 mg adalimumab every other week

Intervention Type BIOLOGICAL

Other Intervention Names

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ABT-D2E7 Humira ABT-D2E7 Humira

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

References

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Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

Reference Type DERIVED
PMID: 27338778 (View on PubMed)

Other Identifiers

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M03-600

Identifier Type: -

Identifier Source: org_study_id