A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission

Pfizer

Status and phase: Terminated; Phase 4

Conditions: Ulcerative Colitis

Treatments: Drug: CP-690,500 5 mg; Drug: CP-690,550 10 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03281304

2017-002274-39 (EudraCT Number)

A3921288

RIVETING STUDY (Other Identifier)

Details and patient eligibility

About

This study is a follow up study for subjects with Ulcerative Colitis (UC) in stable remission designed to evaluate flexible dosing of CP-690,550.

Enrollment: 140 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Currently enrolled in Study A3921139 receiving CP-690,550 10 mg BID for at least 2 years consecutively.
• In stable remission on CP-690,550 10 mg BID
• Agree to use highly effective contraception
• Negative pregnancy test
• Comply with visits, treatments, lab tests, diary and other study procedures
• Signed and dated informed consent document.

Exclusion criteria

• Subjects who were initially assigned to tofacitinib 10 mg BID at baseline of Study A3921139 whose tofacitinib dose was reduced to 5 mg BID due to safety or efficacy.

• Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis or findings suggestive of Crohn's disease

• Likely to require surgery for ulcerative colitis during study

• Expected to receive any prohibited medication

• Expected to receive live or attenuated virus vaccination during study

• Women who are pregnant or breastfeeding or planning to become pregnant during the study

• Evidence of colonic malignancy or any dysplasia

• Acute or chronic medical or psychiatric condition that may increase risk of participation

• Investigator site staff member

• Subjects likely to be uncooperative or unable to comply with study procedures

• Participation in other studies involving investigational drugs during study

• Subjects with any of the following risk factors for pulmonary embolism at baseline as defined by EMA's PRAC:

  • has heart failure;
  • has inherited coagulation disorders;
  • has had venous thromboembolism, either deep venous thrombosis or pulmonary embolism;
  • is taking combined hormonal contraceptives or hormone replacement therapy;
  • has malignancy (association is strongest with cancers other than non-melanoma skin cancers);
  • is undergoing major surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups

CP-690,550 5 mg

Experimental group

Description:

CP-690,550 5 mg tablet by mouth twice a day (BID)

Treatment:

Drug: CP-690,500 5 mg

CP-690,550 10 mg

Experimental group

Description:

CP-690,550 10 mg BID

Treatment:

Drug: CP-690,550 10 mg