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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

adalimumab

placebo

adalimumab

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Vaccines with adalimumab dosing

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Double Blind

Open Label

Arm Description

Outcomes

Primary Outcome Measures

Blood samples for Influenza A & B antibody Assay

Blood Samples for Pneumococcal Antibody Assay

Secondary Outcome Measures

Laboratory assessments

Vitals signs

Adverse events

Full Information

NCT ID

NCT00649922

First Posted

March 28, 2008

Last Updated

March 31, 2008

Sponsor

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT00649922

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

October 2003 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Vaccines with adalimumab dosing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

226 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Double Blind

Arm Type

Placebo Comparator

Arm Title

Open Label

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

placebo

Intervention Description

2 injections Day 1, 1 injection Days 15 and 29

Intervention Type

Biological

Intervention Name(s)

adalimumab

Other Intervention Name(s)

ABT-D2E7, Humira

Intervention Description

40 mg adalimumab every other week

Primary Outcome Measure Information:

Title

Blood samples for Influenza A & B antibody Assay

Time Frame

Baseline (Day 1), Day 36 or premature discontinuation

Title

Blood Samples for Pneumococcal Antibody Assay

Time Frame

Baseline (Day 1), Day 36 or premature discontinuation

Secondary Outcome Measure Information:

Title

Laboratory assessments

Time Frame

Screening, Week 15, Day 36, Month 3 and Month 6

Title

Vitals signs

Time Frame

Screening - Month 6

Title

Adverse events

Time Frame

Screening - Month 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

27338778

Citation

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.

Results Reference

derived

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

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