Phase 2
Completed N=268
A Study To Monitor Long-Term Treatment With PF-00547659
Source: ClinicalTrials.gov NCT01298492 ↗Enrolled (actual)
268
Serious AEs
44.0%
Results posted
Aug 2017
Primary outcomePrimary: Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) — 249; 53; 80 Participants
Summary
This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs) |
249; 53; 80 | — |
| SECONDARY Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies |
63 | — |
| SECONDARY Serum Trough Concentrations of PF-00547659 Versus Time |
6673; 6064; 8040; 9563; 10400; 10450 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects between 18 and 76 years of age.
- Subjects previously enrolled in study A7281006 who have completed the blinded 84 day (12 week) induction period or in study A7281008 who have completed Week 12 and have demonstrated a clinical response as defined by that protocol.
Exclusion Criteria
- Subjects that have completed Day 84 (Week 12) of a PF-00547659 study but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would hinder entry or participation in this study.
- Subjects who are taking any dose of azathioprine, 6-mercaptopurine or methotrexate.
Data sourced from ClinicalTrials.gov (NCT01298492). 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.