inflammatory bowel disease Ulcerative Colitis
Conditions
Interventions
Subjects will be equally randomized to one of the three treatment groups:
• Tofacitinib 10 mg BID orally.
• Tofacitinib 5 mg BID orally.
• Placebo BID orally.
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who met study entry criteria and completed 9-week induction treatment from Study A3921094 or A3921095.;2. Subjects who achieved clinical response in Study A3921094 or A3921095. - Clinical response is defined by a decrease from the induction study baseline (A3921094 or A3921095) Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1. For eligibility assessment, clinical response will be determined based on the central-read endoscopy performed at Week 8 of Study A3921094 or A3921095 and the central-read endoscopy performed at Week 0 of Study A3921094 or A3921095.;3. Women of childbearing potential must test negative for pregnancy prior to study enrollment. - Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 4 weeks after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.;4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, bowel movement diary calls, and other study procedures.;5. Evidence of a personally signed and dated informed consent document(s) indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: 1. Subjects who had major protocol violation (as determined by the Sponsor) in Study A3921094 or A3921095.;2. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn*s disease.;3. Subjects who have had surgery for UC or in the opinion of the investigator, are likely to require surgery for UC during the study period.;4. Subjects who are expected to receive any of prohibited concomitant medications, including medications that are either moderate to potent CYP3A inducers or inhibitors, during the study period as specified in Appendix 2 of the protocol.;5. Subjects who are expected to receive live or attenuated virus vaccination during study period and for 6 weeks after last dose of study drug.;6. Women who are pregnant or breastfeeding, or planning to become pregnant during the study period.;7. Baseline 12-lead ECG that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results (ie, baseline QTcF >450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV block, or serious bradyarrhythmias or tachyarrhythmias; see Appendix 4 of the protocol.;8. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.;9. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.;10. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.;11. Subjects who are participating in or interested in participating in other investigational studies during study A3921096.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • The proportion of subjects in remission at Week 52. Remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key Secondary Endpoints • The proportion of subjects with mucosal healing at Week 52. Mucosal healing is defined by a Mayo endoscopic subscore of 0 or 1. • The proportion of subjects in sustained steroid free remission among subjects in remission at baseline of Study A3921096. Sustained steroid-free remission is defined by being in remission and steroid-free at both Week 24 and Week 52. Steroid free remission is defined by being in remission (a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0) in addition to not requiring any treatment with corticosteroid for at least 4 weeks prior to the visit. Safety Endpoints • Incidence and severity of adverse events. • Incidence of serious infections (see Section 7.2.8). • Incidence of addition of lipid lowering agents. • Incidence and severity of laboratory abnormalities, and change from baseline in clinical laboratory values. • Incidence of vital sign abnormalities and changes from baseline in vital signs. • Incidence of clinically significant changes in physical examination from baseline. • Incidence of electrocardiogram (ECG) abnormalities. • Summary of adjudicated cardiovascular events. • Summary of malignancies confirmed by central laboratory pathologist over-read. | — |
Countries
Netherlands
Outcome results
None listed