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
Verified date | March 2018 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States,
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) |
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