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

• ClinicalTrials.gov Identifier: NCT00649922
• Recruitment Status: Completed
• First Posted: April 1, 2008
• Last Update Posted: April 1, 2008
• Sponsor: Abbott
• Information provided by: Abbott

Tracking Information

• First Submitted Date: March 28, 2008
• First Posted Date: April 1, 2008
• Last Update Posted Date: April 1, 2008
• Study Start Date: October 2003
• Actual Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 31, 2008)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 31, 2008)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis

Intervention

• 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
• Biological: adalimumab
  40 mg adalimumab every other week
  Other Names:

  • ABT-D2E7
  • Humira

Study Arms

• Placebo Comparator: Double Blind
  Interventions:

  • Biological: adalimumab
  • Biological: placebo
• Experimental: Open Label
  Intervention: Biological: adalimumab

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 31, 2008): 226
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 2005
• Actual Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00649922
• Other Study ID Numbers: M03-600
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Lawrence McNamee, Sr. Clinical Research Manager, Abbott
• Original Responsible Party: Same as current
• Current Study Sponsor: Abbott
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Abbott
• Verification Date: March 2008