Impact of Adalimumab on Patient-reported Outcomes in Ulce... | NCT02506179

Studies
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

NCT02506179

Sponsor

AbbVie

Status

Completed

Last Update Posted

Jan 25, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Ulcerative Colitis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 18, 2015Actual

Primary Completion Date

Feb 10, 2020Actual

Completion Date

Feb 10, 2020Actual

First Submitted Date

Jun 26, 2015

First Submission Date that Met QC Criteria

Jul 21, 2015

First Posted Date

Jul 23, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2021

Last Update Posted Date

Jan 25, 2021Actual

Name	Class
Cato Research	INDUSTRY

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Label	Type	Description	Intervention Names
Open-label cohort		Patients will be followed for 52 weeks post initiation of adalimumab (Week 0).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in depressive symptoms at Week 52	It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).	From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in depressive symptoms at Week 8	It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).	From Week 0 to Week 8, or at the time of stopping adalimumab, or at the time of Premature Discontinuation
Change from baseline in the proportion of patients with PHQ-9 >= 10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient must voluntarily sign and date a patient authorization.
Patient must be ≥ 18 years of age.
Patient must have confirmed diagnosis of UC.
Patient must have:
1. a Mayo endoscopic sub score of 2 or 3 from endoscopic investigation in the previous 3-months that is closest to the baseline visit or
2. a Mayo rectal bleeding subscore ≥ 2 and a calprotectin value greater than 250 µg/gr.
Patient must have been prescribed adalimumab as part of his treatment by his treating physician.
If the patient was previously treated with vedolizumab or any anti-TNF agent (except adalimumab), an appropriate washout has taken place as per routine practice.

Exclusion Criteria:

Patient has previously received adalimumab.
Patient has previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
Patient with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
Patient with a current diagnosis of indeterminate colitis, ulcerative proctitis only, or with a current diagnosis and/or have a history of Crohn's disease.
Patient with other tumor necrosis factor (TNF) immune-modulated disease.
Patient has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study.
A female patient is pregnant or breast-feeding.
Patient is currently participating in another prospective study including controlled clinical trials and observational studies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult males and females with moderate to severe UC patients from Canada who meet the inclusion criteria and who do not meet any of the exclusion criteria will be eligible for enrollment into the study.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary /ID# 144032		Calgary	Alberta	T2N 4Z6	Canada
Zeidler Ledcor Centre /ID# 145973

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases