Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

AbbVie100 enrolled

Overview

To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Ulcerative Colitis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (23)

University of Calgary /ID# 144032

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

Change from baseline in depressive symptoms at Week 52

It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).

Time frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Secondary Outcomes

Change from baseline in depressive symptoms at Week 8

It is measured by the Patient Health Questionnaire - 9 Items (PHQ-9).

Time frame: 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

The change from baseline in the proportion of patients with PHQ-9 \>= 10 is assessed at week 8 and 52.

Time frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Disability

It is measured by the Inflammatory Bowel Disease (IBD) Disability Index at weeks 8 and 52.

Time frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Overall quality of life

It is measured by the EuroQol 5-Dimensions, 5 Levels (EQ-5D-5L) and EQ5D VAS at weeks 8 and 52.

Time frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Ulcerative Colitis (UC)-specific quality of life

It is measured by the Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) at weeks 8 and 52.

Time frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Zeidler Ledcor Centre /ID# 145973

Edmonton, Alberta, Canada

Columbia Gastro Mgmnt Ltd /ID# 136820

New Westminster, British Columbia, Canada

GIRI Gastrointestinal Research Institute /ID# 141107

Vancouver, British Columbia, Canada

Discovery Clinical Services /ID# 144102

Victoria, British Columbia, Canada

Percuro Clinical Research, Ltd /ID# 136533

Victoria, British Columbia, Canada

Dr. Everett Chalmers Reg Hosp. /ID# 136534

Fredericton, New Brunswick, Canada

Dr Chadwick Ian Williams Professional Corporation /ID# 144802

Saint John, New Brunswick, Canada

Bellini Medicine Professional /ID# 144241

Brampton, Ontario, Canada

Oshawa Clinic /ID# 144364

Oshawa, Ontario, Canada

...and 13 more locations

Change from baseline in Fatigue

It is measured by the Functional Assessment Chronic Illness Therapy-Fatigue (FACIT-F) at weeks 8 and 52.

Time frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Sleep impairment,

It is measured by the Medical Outcomes Study Sleep scale (MOS Sleep) at weeks 8 and 52.

Time frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Work productivity

The change from baseline in work productivity is assessed at week 8 and 52.

Time frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Assessing Simple Clinical Colitis Activity Index (SCCAI)

SCCAI is used to access response and remission rates.

Time frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Fecal Calprotectin levels

The change from baseline in Fecal Calprotectin levels will be assessed.

Time frame: From Week 0 to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Mayo endoscopic sub-score

Mayo endoscopic sub-score will be assessed.

Time frame: Up to Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Proportion of patients with Complications including hospitalization and surgery

The proportion of patients with complications including hospitalization and surgery will be assessed.

Time frame: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Proportion of patients on steroids

The proportion of patients on steroids will be assessed.

Time frame: At Week 52, or at the time of stopping adalimumab, or at the time of Premature Discontinuation

Change from baseline in Physician's Global Assessment (PGA)

The change from baseline in Physician's Global Assessment (PGA) will be assessed.

Time frame: From Week 0 to Week 52 or at the time of stopping adalimumab, or at the time of Premature Discontinuation