An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis (OPAL)

Janssen (J&J Innovative Medicine)

Status: Active, not recruiting

Conditions: Ulcerative Colitis

Study type: Observational

Funder types: Industry

Identifiers

NCT02808780

CNTO148UCO4001 (Other Identifier)

CR105891

Details and patient eligibility

About

The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.

Enrollment: 537 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past

• For enrollment into the Simponi-exposed cohort meets one of the following:

  1. The participant is currently receiving Simponi ,or
  2. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
  3. The participant is scheduled to receive Simponi within 30 days after enrollment

• For Thiopurine cohort:

  1. The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
  2. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
  3. Participant may have received biologics other than Simponi or investigational agents prior to enrollment

Exclusion criteria

• Participants who cannot be treated with Simponi or thiopurines
• Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment
• Participants currently receiving an investigational or biologic agent other than Simponi
• Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Trial design

537 participants in 2 patient groups

Simponi-exposed cohort

Description:

Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment.

Thiopurine cohort

Description:

Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment.