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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tofacitinib
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NEA Baptist Clinic
  • Drug Shipping Address (IRB# 14-000826) Ronald Regan
  • UCLA David Geffen School of Medicine
  • Pacific Arthritis Center Medical Group
  • Inland Rheumatology Clinical Trials, Inc.
  • Jacksonville Center for Clinical Research
  • Center for Arthritis and Rheumatic Diseases
  • Suncoast Clinical Research, Inc.
  • DMI Research, Inc.
  • Florida Arthritis and Osteoporosis Center
  • Gulf Coast Medical Center
  • Suncoast Medical Clinic
  • Sun Coast Medical Clinic
  • Sarasota Arthritis Research Center
  • Health Point Medical Group, Inc.
  • Deerbrook Medical Associates
  • Diagnostic Rheumatology And Research, PC
  • Arthritis Treatment Center
  • Dartmouth-Hitchcock Medical Center
  • The Center for Rheumatology, LLP
  • Buffalo Rheumatology and Medicine, PLLC
  • Piedmont Rheumatology, P.A
  • PMG Research of Hickory, LLC
  • PMG Research of Salisbury, LLC
  • Novant Health Imaging Julian Road
  • East Penn Rheumatology Associates, PC
  • Altoona Center for Clinical Research
  • Clinical Research Center of Reading LLP
  • Palmetto Clinical Trial Services, LLC
  • Arthritis Clinic
  • West Tennessee Research Institute
  • Rheumatology Consultants, PLLC
  • Office of John P. Lavery, MD, PA
  • Baylor Research Institute Arthritis Care and Research Center
  • The Vancouver Clinic (Drug Shipment Only)
  • The Vancouver Clinic, Inc, PS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tofacitinib 5 mg BID (oral) (70 subjects)

Placebo tofacitinib BID (oral) (70 subjects)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).

Secondary Outcome Measures

Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12
Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12
The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.
Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12
VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder.

Full Information

First Posted
May 22, 2014
Last Updated
March 13, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02147587
Brief Title
A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib 5 mg BID (oral) (70 subjects)
Arm Type
Experimental
Arm 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.
Arm Title
Placebo tofacitinib BID (oral) (70 subjects)
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tofacitinib
Intervention Description
5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets twice daily with background methotrexate for 12 weeks
Primary Outcome Measure Information:
Title
Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
Description
VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame
Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
Secondary Outcome Measure Information:
Title
Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12
Time Frame
Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Title
Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12
Description
The absolute geometric mean titer (GMT) of VZV-specific IgG levels was calculated from logarithmically transformed assay values.
Time Frame
Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Title
Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12
Description
VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder.
Time Frame
Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to Week 16 that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Zoster Vaccine-Related AEs by System Organ Class
Description
Zoster vaccine-related AEs included General Disorders and Administration Site Conditions (injection site erythema, pain, pruritis, rash, swelling; vaccination site erythema, pruritus, rash), Infections and Infestations (disseminated herpes zoster), and Musculoskeletal and Connective Tissue Disorders (myalgia). All zoster vaccine-related AEs were mild, except for the herpes zoster AE classified under Infections and Infestations, which was moderate in severity.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinical Herpes Zoster Events by Severity
Description
Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Clinically Significant Abnormal Laboratory Parameters
Description
Participants with the following abnormalities were discontinued from the study: 2 sequential absolute neutrophil counts (ANC) <1000/mm^3; 2 sequential hemoglobin values <8.0 g/dL or decreases of >30% from baseline value; 2 sequential absolute lymphocyte count <500/mm^3; 2 sequential platelet counts <75,000/mm^3; 2 sequential alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations >=3 times the upper limit of normal (X ULN) with a total bilirubin value >=2X ULN, elevated international normalized ratio (INR), or accompanied by signs/symptoms consistent with hepatic injury; 2 sequential ALT or AST elevations >=5X ULN regardless of total bilirubin or accompanying symptoms; confirmed increases in serum creatinine (SCr) >50% over the average of screening and baseline values; a confirmed positive urine pregnancy test or refusal to use appropriate contraception in a woman of childbearing potential.
Time Frame
Baseline up to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
NEA Baptist Clinic
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Drug Shipping Address (IRB# 14-000826) Ronald Regan
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pacific Arthritis Center Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Inland Rheumatology Clinical Trials, Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Center for Arthritis and Rheumatic Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
DMI Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Florida Arthritis and Osteoporosis Center
City
Port Richey
State/Province
Florida
ZIP/Postal Code
34668
Country
United States
Facility Name
Gulf Coast Medical Center
City
Port Richey
State/Province
Florida
ZIP/Postal Code
34668
Country
United States
Facility Name
Suncoast Medical Clinic
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Sun Coast Medical Clinic
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Sarasota Arthritis Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Health Point Medical Group, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Deerbrook Medical Associates
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Facility Name
Diagnostic Rheumatology And Research, PC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Arthritis Treatment Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Center for Rheumatology, LLP
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
Buffalo Rheumatology and Medicine, PLLC
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
Piedmont Rheumatology, P.A
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
PMG Research of Hickory, LLC
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Novant Health Imaging Julian Road
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28147
Country
United States
Facility Name
East Penn Rheumatology Associates, PC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Clinical Research Center of Reading LLP
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Arthritis Clinic
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Rheumatology Consultants, PLLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909-1907
Country
United States
Facility Name
Office of John P. Lavery, MD, PA
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Baylor Research Institute Arthritis Care and Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The Vancouver Clinic (Drug Shipment Only)
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
The Vancouver Clinic, Inc, PS
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34870800
Citation
Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
Results Reference
derived
PubMed Identifier
33127856
Citation
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
Results Reference
derived
PubMed Identifier
32816215
Citation
Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. Erratum In: Dig Dis Sci. 2020 Oct 10;:
Results Reference
derived
PubMed Identifier
28845577
Citation
Winthrop KL, Wouters AG, Choy EH, Soma K, Hodge JA, Nduaka CI, Biswas P, Needle E, Passador S, Mojcik CF, Rigby WF. The Safety and Immunogenicity of Live Zoster Vaccination in Patients With Rheumatoid Arthritis Before Starting Tofacitinib: A Randomized Phase II Trial. Arthritis Rheumatol. 2017 Oct;69(10):1969-1977. doi: 10.1002/art.40187. Epub 2017 Sep 6.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921237&StudyName=A%20Study%20to%20Assess%20Immune%20Response%20Following%20Zoster%20Vaccination%20to%20Subjects%20with%20Rheumatoid%20Arthritis%20Receiving%20Tofacitinib%20or%20Placebo%20with
Description
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A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

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