Phase 2
Completed N=223
A Study To Assess the Immune Response Following Administration Of Influenza and Pneumococcal Vaccines To Subjects With Rheumatoid Arthritis Receiving CP-690,550 Or Placebo
Source: ClinicalTrials.gov NCT01359150 ↗Enrolled (actual)
223
Serious AEs
2.2%
Results posted
Mar 2013
Primary outcomePrimary: Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) — 45.1; 68.4; 31.6; 61.8 percentage of participants
Summary
A Randomized, Double Blind, Placebo Controlled Phase 2 Study To assess the Immune Response Following Administration of Influenza and Pneumococcal Vaccines to Subjects with Rheumatoid Arthritis receiving CP-690,550 with and Without background Methotrexate
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Satisfactory Humoral Response to the Pneumococcal Vaccine at Visit 3 (Day 64) |
45.1; 68.4; 31.6; 61.8; 62.2; 76.7 | — |
| PRIMARY Percentage of Participants With Satisfactory Humoral Response to the Seasonal Influenza Vaccine at Visit 3 (Day 64) |
56.9; 62.2; 50.9; 58.2; 64.4; 67.4 | — |
| SECONDARY Percentage of Participants Who Responded to Each of the 12 Pneumococcal Antigens |
59.8; 69.4; 52; 61.2; 59.8; 70.4 | — |
| SECONDARY Percentage of Participants Who Responded to Each of the 3 Influenza Antigens |
38.2; 52; 60.8; 63.3; 60.8; 69.4 | — |
| SECONDARY Percentage of Participants With Protective Antibody Titers to the Seasonal Influenza Vaccine |
76.5; 91.8; 64.9; 92.7; 91.1; 90.7 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of Anti-Pneumococcal Antibody Levels to Each of the 12 Pneumococcal Antigens Above Vaccination Baseline Values (Day 29) |
4.75; 6.83; 2.68; 3.90; 3.10; 4.82 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) of Anti-Influenza Antibody Levels to Each of the Influenza Antigens Above Vaccination Baseline Values (Day 29) |
2.95; 3.90; 6.04; 9.50; 7.11; 9.06 | — |
| SECONDARY Geometric Mean Concentrations (GMC) of Anti-Pneumococcal Antibody |
1.81; 3.27; 5.24; 6.40; 2.53; 4.60 | — |
| SECONDARY Geometric Mean Titer (GMT) of Anti-Influenza Antibody |
33.39; 50.74; 86.40; 221.5; 132.3; 244.0 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must meet the American College of Rheumatology (ACR) classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
- The subject must have active disease at both screening and baseline
Exclusion Criteria
- History of any documented influenza or pneumococcal infection within the last 3 months.
- Receipt of any vaccine within 1 month prior to the initial study drug administration (CP-690,550 or placebo CP-690,550).
- If a subject has received an influenza vaccine within 6 months or a pneumococcal vaccine within 5 years of initial study drug administration.
Data sourced from ClinicalTrials.gov (NCT01359150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.