A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate
|ClinicalTrials.gov Identifier: NCT02147587|
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : April 11, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Tofacitinib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||112 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Actual Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||July 2015|
Experimental: Tofacitinib 5 mg BID (oral) (70 subjects)
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.
5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
Placebo Comparator: Placebo tofacitinib BID (oral) (70 subjects)
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.
Placebo tablets twice daily with background methotrexate for 12 weeks
- Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4 [ Time Frame: Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination) ]VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).
- 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) ]
- Absolute Values in VZV-Specific IgG Levels at Day 1, Week 4 and Week 12 [ Time Frame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) ]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 [ Time Frame: Day 1 (2 weeks post-vaccination), Week 4 (6 weeks post-vaccination), Week 12 (14 weeks post-vaccination) ]VZV-specific IgG levels as measured by ELISA. A ratio greater than or equal to (>=)1.5 was defined as a responder.
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 16 ]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.
- Number of Participants With Zoster Vaccine-Related AEs by System Organ Class [ Time Frame: Baseline up to Week 16 ]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.
- Number of Participants With Clinical Herpes Zoster Events by Severity [ Time Frame: Baseline up to Week 16 ]Clinical herpes is manifested as mild, moderate, or severe disseminated herpes zoster.
- Number of Participants With Clinically Significant Abnormal Laboratory Parameters [ Time Frame: Baseline up to Week 16 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147587
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|