A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

A Randomized, Double-blind, Placebo-controlled, Phase 2 Study To Assess The Immune Response Following Administration Of Zoster Vaccine To Subjects With Rheumatoid Arthritis Receiving Tofacitinib (Cp-690,550) Or Placebo With Background Methotrexate Treatment

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
Brief Summary

This study will evaluate immune response following administration of zoster vaccine in subjects with rheumatoid arthritis who are receiving background methotrexate and initiate 5 mg twice daily of tofacitinib or placebo for tofacitinib 2 to 3 weeks following vaccination.

Overall Status Completed
Start Date June 2014
Completion Date July 2015
Primary Completion Date June 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
Secondary Outcome
Measure Time Frame
Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12 Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12 Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12 Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Enrollment 112
Condition
Intervention

Intervention Type: Drug

Intervention Name: Tofacitinib

Description: 5 mg twice daily of tofacitinib with background methotrexate for 12 weeks

Arm Group Label: Tofacitinib 5 mg BID (oral) (70 subjects)

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo tablets twice daily with background methotrexate for 12 weeks

Arm Group Label: Placebo tofacitinib BID (oral) (70 subjects)

Eligibility

Criteria:

Inclusion Criteria:

- Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate as defined by the American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive protein (CRP).

- Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before vaccination.

- Subjects must have active disease at screening and baseline.

- Must be at least 50 years of age or older.

Exclusion Criteria:

- History of receiving any varicella-zoster virus vaccine

- Receipt of any vaccines within 6 weeks of first dose of study treatment.

- Subjects with current infections or history of infections.

- History of recurrent (more than one episode) of herpes zoster or disseminated (a single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.

Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
NEA Baptist Clinic | Jonesboro, Arkansas, 72401, United States
Drug Shipping Address (IRB# 14-000826) Ronald Regan | Los Angeles, California, 90095, United States
UCLA David Geffen School of Medicine | Los Angeles, California, 90095, United States
Pacific Arthritis Center Medical Group | Santa Maria, California, 93454, United States
Inland Rheumatology Clinical Trials, Inc. | Upland, California, 91786, United States
Jacksonville Center for Clinical Research | Jacksonville, Florida, 32216, United States
Center for Arthritis and Rheumatic Diseases | Miami, Florida, 33173, United States
Suncoast Clinical Research, Inc. | New Port Richey, Florida, 34652, United States
DMI Research, Inc. | Pinellas Park, Florida, 33782, United States
Florida Arthritis and Osteoporosis Center | Port Richey, Florida, 34668, United States
Gulf Coast Medical Center | Port Richey, Florida, 34668, United States
Suncoast Medical Clinic | Saint Petersburg, Florida, 33705, United States
Sun Coast Medical Clinic | Saint Petersburg, Florida, 33710, United States
Sarasota Arthritis Research Center | Sarasota, Florida, 34239, United States
Health Point Medical Group, Inc. | Tampa, Florida, 33614, United States
Deerbrook Medical Associates | Vernon Hills, Illinois, 60061, United States
Diagnostic Rheumatology And Research, PC | Indianapolis, Indiana, 46227, United States
Arthritis Treatment Center | Frederick, Maryland, 21702, United States
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
The Center for Rheumatology, LLP | Albany, New York, 12206, United States
Buffalo Rheumatology and Medicine, PLLC | Orchard Park, New York, 14127, United States
Piedmont Rheumatology, P.A | Hickory, North Carolina, 28602, United States
PMG Research of Hickory, LLC | Hickory, North Carolina, 28602, United States
PMG Research of Salisbury, LLC | Salisbury, North Carolina, 28144, United States
Novant Health Imaging Julian Road | Salisbury, North Carolina, 28147, United States
East Penn Rheumatology Associates, PC | Bethlehem, Pennsylvania, 18015, United States
Altoona Center for Clinical Research | Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading LLP | Wyomissing, Pennsylvania, 19610, United States
Palmetto Clinical Trial Services, LLC | Greenville, South Carolina, 29601, United States
Arthritis Clinic | Jackson, Tennessee, 38305, United States
West Tennessee Research Institute | Jackson, Tennessee, 38305, United States
Rheumatology Consultants, PLLC | Knoxville, Tennessee, 37909-1907, United States
Office of John P. Lavery, MD, PA | Allen, Texas, 75013, United States
Baylor Research Institute Arthritis Care and Research Center | Dallas, Texas, 75231, United States
The Vancouver Clinic (Drug Shipment Only) | Vancouver, Washington, 98664, United States
The Vancouver Clinic, Inc, PS | Vancouver, Washington, 98664, United States
Location Countries

United States

Verification Date

March 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Tofacitinib 5 mg BID (oral) (70 subjects)

Type: Experimental

Description: Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.

Label: Placebo tofacitinib BID (oral) (70 subjects)

Type: Placebo Comparator

Description: Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov