A Prospective Observational Study for Evaluation of Safety and Effectiveness of Rinvoq in Moderately to Severely Active Ulcerative Colitis; a Japanese Post-Marketing Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ulcerative Colitis
- Sponsor
- AbbVie
- Enrollment
- 308
- Locations
- 114
- Primary Endpoint
- Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR)
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.
Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult participants will be enrolled in Japan.
Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 60 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants diagnosed with moderately to severely active Ulcerative colitis (UC).
- •Participants who are within 14 days from the commencement of Rinvoq treatment for UC.
- •Participants who are administered the first dose of Rinvoq for UC after approval for UC in Japan.
Exclusion Criteria
- •Participants currently participating in registrational clinical trial.
- •Participants for whom Rinvoq is contraindicated.
- •Participants that have been previously exposed to Rinvoq.
Outcomes
Primary Outcomes
Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR)
Time Frame: Up to 60 weeks
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.