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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147587
• Other study ID #: A3921237
• Secondary ID: 2014-000706-34
• Status: Completed
• Phase: Phase 2
• First received: May 22, 2014
• Last updated: March 13, 2018
• Start date: June 2014
• Est. completion date: July 2015

Study information

• Verified date: March 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tofacitinib
5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
• Placebo
Placebo tablets twice daily with background methotrexate for 12 weeks

Locations

Country	Name	City	State
United States	The Center for Rheumatology, LLP	Albany	New York
United States	Office of John P. Lavery, MD, PA	Allen	Texas
United States	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania
United States	Baylor Research Institute Arthritis Care and Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Arthritis Treatment Center	Frederick	Maryland
United States	Palmetto Clinical Trial Services, LLC	Greenville	South Carolina
United States	Piedmont Rheumatology, P.A	Hickory	North Carolina
United States	PMG Research of Hickory, LLC	Hickory	North Carolina
United States	Diagnostic Rheumatology And Research, PC	Indianapolis	Indiana
United States	Arthritis Clinic	Jackson	Tennessee
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Rheumatology Consultants, PLLC	Knoxville	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Drug Shipping Address (IRB# 14-000826) Ronald Regan	Los Angeles	California
United States	UCLA David Geffen School of Medicine	Los Angeles	California
United States	Center for Arthritis and Rheumatic Diseases	Miami	Florida
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Buffalo Rheumatology and Medicine, PLLC	Orchard Park	New York
United States	DMI Research, Inc.	Pinellas Park	Florida
United States	Florida Arthritis and Osteoporosis Center	Port Richey	Florida
United States	Gulf Coast Medical Center	Port Richey	Florida
United States	Sun Coast Medical Clinic	Saint Petersburg	Florida
United States	Suncoast Medical Clinic	Saint Petersburg	Florida
United States	Novant Health Imaging Julian Road	Salisbury	North Carolina
United States	PMG Research of Salisbury, LLC	Salisbury	North Carolina
United States	Pacific Arthritis Center Medical Group	Santa Maria	California
United States	Sarasota Arthritis Research Center	Sarasota	Florida
United States	Health Point Medical Group, Inc.	Tampa	Florida
United States	Inland Rheumatology Clinical Trials, Inc.	Upland	California
United States	The Vancouver Clinic (Drug Shipment Only)	Vancouver	Washington
United States	The Vancouver Clinic, Inc, PS	Vancouver	Washington
United States	Deerbrook Medical Associates	Vernon Hills	Illinois
United States	Clinical Research Center of Reading LLP	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	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.	Baseline up to Week 16
Other	Number of Participants With Zoster Vaccine-Related AEs by System Organ Class	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.	Baseline up to Week 16
Other	Number of Participants With Clinical Herpes Zoster Events by Severity	Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster.	Baseline up to Week 16
Other	Number of Participants With Clinically Significant Abnormal Laboratory Parameters	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.	Baseline up to Week 16
Primary	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).	Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)
Secondary	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)
Secondary	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.	Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)
Secondary	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.	Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination)

External Links

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