Clinical trial NCT02147587: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 112
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
timeFrame: Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
Secondary outcomes:
measure: Fold Change From Baseline in VZV-Specific IgG Levels at Day 1 and Week 12
timeFrame: Baseline (pre-vaccination; Day -14), Day 1 (2 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
measure: Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12
timeFrame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
measure: Percentage of Participants With >=1.5 Fold Change in VZV-Specific IgG Levels Day 1, Week 4 and Week 12
timeFrame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 16
measure: Number of Participants With Zoster Vaccine-Related AEs by System Organ Class
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinical Herpes Zoster Events by Severity
timeFrame: Baseline up to Week 16
measure: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
timeFrame: Baseline up to Week 16
Locations:
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Los Angeles
country: United States
facility: Drug Shipping Address (IRB# 14-000826) Ronald Regan
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Miami
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Pinellas Park
country: United States
facility: DMI Research, Inc.
state: Florida
city: Port Richey
country: United States
facility: Florida Arthritis and Osteoporosis Center
state: Florida
city: Port Richey
country: United States
facility: Gulf Coast Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Suncoast Medical Clinic
state: Florida
city: Saint Petersburg
country: United States
facility: Sun Coast Medical Clinic
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Tampa
country: United States
facility: Health Point Medical Group, Inc.
state: Florida
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology And Research, PC
state: Indiana
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: The Center for Rheumatology, LLP
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology and Medicine, PLLC
state: New York
city: Hickory
country: United States
facility: Piedmont Rheumatology, P.A
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Salisbury
country: United States
facility: Novant Health Imaging Julian Road
state: North Carolina
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading LLP
state: Pennsylvania
city: Greenville
country: United States
facility: Palmetto Clinical Trial Services, LLC
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants, PLLC
state: Tennessee
city: Allen
country: United States
facility: Office of John P. Lavery, MD, PA
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute Arthritis Care and Research Center
state: Texas
city: Vancouver
country: United States
facility: The Vancouver Clinic (Drug Shipment Only)
state: Washington
city: Vancouver
country: United States
facility: The Vancouver Clinic, Inc, PS
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.