NCT00649922

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_4 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

1.2 years

First QC Date

March 28, 2008

Last Update Submit

March 31, 2008

Conditions

Rheumatoid Arthritis

Keywords

Vaccines with adalimumab dosing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Laboratory assessments

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

  • Vitals signs

    Screening - Month 6

  • Adverse events

    Screening - Month 6

Study Arms (2)

Double Blind

PLACEBO COMPARATOR
Biological: adalimumabBiological: placebo

Open Label

EXPERIMENTAL
Biological: adalimumab

Interventions

adalimumabBIOLOGICAL

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

Also known as: ABT-D2E7, Humira
Double Blind
placeboBIOLOGICAL

2 injections Day 1, 1 injection Days 15 and 29

Double Blind

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27338778DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

October 1, 2003

Primary Completion

December 1, 2004

Study Completion

February 1, 2005

Last Updated

April 1, 2008

Record last verified: 2008-03