Crohn's disease MedDRA version: 17.1 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 100000004856
Conditions
Interventions
Product Name: Tofacitinib
Product Code: CP-690,550-10
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tofacitinib
CAS Number: 540737-29-9
Current Sponsor code: CP-690,550-10
Concentration
Sponsors
Pfizer Inc.235 East 42nd Street, New York, NY 10017, USA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who met study entry criteria, and who completed Week 8 visit of Induction Study A3921083. 2. Subjects who achieve clinical response-100 (reduction in CDAI by = 100 points) and/or clinical remission (CDAI=65 years) yes F.1.3.1 Number of subjects for this age range 24
Exclusion criteria
Exclusion criteria: 1.Subjects who had major protocol violation (as determined by the Sponsor) in the A3921083 study. 2.Fecal culture/toxin assay indicating presence of pathogenic infection, unless the subject has completed a full course of treatment or, if treatment is ongoing, be clinically improved in the judgement of the investigator. 3.Presence of active (draining) fistulae, intrabdominal or perineal collection or abscess (MRI imaging is not required for entry to this study unless clinically indicated). 4.Subjects with evidence of or suspected liver disease ie, liver injury due to methotrexate or primary sclerosing cholangitis. 5.Subjects with evidence of blood dyscrasias at baseline visit (as assessed by the laboratory results from Week 7 of A3921083): Hemoglobin levels 450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV block, or serious bradyarrhythmias or tachyarrhythmias; see Appendix 3 of protocol) 12.Subjects who are expected to receive prohibited concomitant medications including medications that are either moderate to potent CYP3A4 inducers or inhibitors during the study period. 13.Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures. 14.Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial. 15.Subjects who are participating in or interested in participating in other investigational studies during study A3921084. 16.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the safety and tolerability of CP-690,550 as a maintenance therapy in subjects with active Crohn’s disease. • To estimate the effect of CP-690,550 as a maintenance therapy on clinical remission, sustained remission and sustained response rates in subjects with Crohn’s disease. • To evaluate the pharmacokinetics of CP-690,550 as a maintenance therapy in subjects with moderate to severe Crohn’s disease. • To evaluate the effect of CP-690,550 as a maintenance therapy on quality of life in subjects with moderate to severe Crohn’s disease. • To evaluate the effect of CP-690,550 as a maintenance therapy on CRP and fecal calprotectin. ;Main Objective: The primary objective of the study is to estimate the effects of CP-690,550 in maintaining a clinical response or being in remission in subjects with moderate to severe Crohn’s disease previously achieving clinical response or remission in induction Study A3921083.;Primary end point(s): The proportion of subjects maintaining clinical response-100, as defined by a decrease in CDAI score at least 100 points from A3921083 baseline, or being in clinical remission, as defined by a CDAI score less than 150, at Week 26.;Timepoint(s) of evaluation of this end point: The proportion of subjects maintaining clinical response-100, as defined by a decrease in CDAI score at least 100 points from A3921083 baseline, or being in clinical remission, as defined by a CDAI score less than 150, at week 26. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The proportion of subjects maintaining clinical response-100 or being in clinical remission at Weeks 4, 8, 12, 20 and 26 from the A3921083 Baseline. • The proportion of subjects maintaining at least a clinical response-100 at Weeks 4, 8, 12, 20 and 26. • The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20 and 26. • The proportion of subjects in clinical remission at Weeks 4, 8, 12, 20, and 26 among subjects in clinical remission at baseline of maintenance study. • The proportion of subjects in sustained clinical remission in the maintenance phase. Sustained clinical remission is defined as being in clinical remission at both Weeks 20 and 26. • The proportion of subjects achieving sustained clinical response in the maintenance phase. Sustained clinical response is defined as having at least a clinical response-100 at both Weeks 20 and 26 from the A3921083 Baseline. • CDAI scores over time and CDAI scores change from Baseline. • The time to relapse. Relapse is defined as increase in CDAI of >100 points from the maintenance phase baseline and a CDAI score of >220 points. • The proportion of subjects achieving a steroid-free clinical remission at Week 26 of the maintenance phase among subjects on steroids at baseline. • Serum CRP and fecal calprotectin over time and change from baseline in CRP and fecal calprotectin. • Plasma concentrations of CP-690,550.;Timepoint(s) of evaluation of this end point: See Secondary Endpoints in section E.5.2. above | — |
Countries
Australia, Austria, Bulgaria, Canada, Croatia, Czech Republic, France, Germany, Greece, Hungary, Israel, Japan, Korea, Republic of, Netherlands, South Africa, Spain, Sweden, Ukraine, United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer Inc.
Outcome results
None listed