Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada (GRACE)

• ClinicalTrials.gov Identifier: NCT04080856
• Recruitment Status: Recruiting
• First Posted: September 6, 2019
• Last Update Posted: December 21, 2020
• Sponsor: AbbVie
• Information provided by (Responsible Party): AbbVie

Tracking Information

• First Submitted Date: September 4, 2019
• First Posted Date: September 6, 2019
• Last Update Posted Date: December 21, 2020
• Actual Study Start Date: December 4, 2019
• Estimated Primary Completion Date: June 9, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 5, 2019)

Change in Dysmenorrhea Score [ Time Frame: From Baseline (Month 0) to Month 6 ]

Dysmenorrhea is evaluated through 11-point numeric rating scale (NRS), where 0 = no pain and 10 = worst imaginable pain

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 5, 2019)

• Percentage of Participants With Patient Global Impression of Change (PGIC) Response [ Time Frame: Up to approximately 18 months ]
  PGIC is a questionnaire-based assessment of endometriosis-related pain is since initiation of study drug.
• Percentage of Participants With Clinician's Global Impression of Change (CGIC) Response [ Time Frame: Up to approximately 18 months ]
  CGIC score is summarized assessment of clinical diagnosis of patient's illness by clinician in relative to a baseline state.
• Change From Baseline in Non-Menstrual Pelvic Pain (NMPP) [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
  The NMPP pain scale ranges from 0 (none) to 3 (severe) as recorded in a daily electronic diary.
• Change From Baseline in Dyspareunia Score [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
  Dyspareunia pain scale ranges from 0 (absent) to 3 (severe).
• Change From Baseline in Pelvic Pain During Periods [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
  Change in pelvic pain is patient reported questionnaire to rate the severity of pelvic pain during periods on the scale of 0 to 10, where 0 = no pain and 10 = worst imaginable pain.
• Change from Baseline in Bleeding and Menstrual Cycle [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
  Uterine bleeding was reported by participants during the study using the e-Diary.
• Percentage of Participants With Change in Dosing Schedule [ Time Frame: Up to approximately 18 months ]
  Percentage of participants who change dose as well as the reasons for change will be tabulated.
• Change from Baseline in Morisky Medication Adherence Scale (MMAS) [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
  The Morisky Medication Adherence Scale (MMAS) is a 4-item questionnaire assessing the risk of non-adherence to medications.
• Percentage of Participants Using Concomitant Medications/Treatments [ Time Frame: Up to approximately 18 months ]
  Percentage of participants using concomitant medications/treatments is assessed.
• Percentage of Participants Using Other Medications/Treatments [ Time Frame: Up to approximately 18 months ]
  Percentage of participants using other medications/treatments for endometriosis is assessed.
• Percentage of Participants Using Pain/Rescue Medications [ Time Frame: Up to approximately 18 months ]
  Percentage of participants using pain/rescue medications is assessed.
• Percentage of Participants Using Add-Back [ Time Frame: Up to approximately 18 months ]
  Percentage of participants with use of add-back is reported
• Change from Baseline in Endometrial Health Profile (EHP)-30 [ Time Frame: From Baseline (Week 0) to approximately 12 months ]
  EHP-30 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis. EHP-30 covers 5 dimensions: pain, control and powerlessness, social support, emotional wellbeing, and self-image.
• Change from Baseline in Endometrial Health Profile (EHP)-5 [ Time Frame: Up to approximately 6 months post-treatment (Month 12) ]
  EHP-5 is a disease-specific self-administered questionnaire used to measure health related QoL in women with endometriosis.
• Change from Baseline in Work Productivity and Activity Impairment (WPAI) [ Time Frame: From Baseline (Week 0) to approximately 18 months ]
  WPAI questionnaire is used to measure the effect of general health and symptom severity on work productivity and regular activities during the past seven days.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
• Official Title: Real-World Experience of Elagolix For the Treatment of Endometriosis in Canada: An Observational Cohort Study (GRACE)
• Brief Summary: The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Premenopausal participants with endometriosis
• Condition: Endometriosis
• Intervention: Not Provided

Study Groups/Cohorts

Participants with endometriosis

Premenopausal participants with endometriosis receiving elagolix in real-world setting

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 5, 2019): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 9, 2023
• Estimated Primary Completion Date: June 9, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Prescribed elagolix as part of standard treatment
• Naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study
• Symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea
• Has provided written informed consent allowing the use of their data for the study

Exclusion Criteria:

• Did not consent
• Cannot fill out questionnaires
• Prescribed elagolix for a period of 1 or 2 months only
• Post-menopausal (naturally or surgically)
• Symptomatic uterine fibroid(s)
• Had medical treatment for uterine fibroids (any length of treatment)

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: ABBVIE CALL CENTER; 844-663-3742; abbvieclinicaltrials@abbvie.com

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT04080856
• Other Study ID Numbers: P19-933
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: AbbVie
• Study Sponsor: AbbVie
• Collaborators: Not Provided

Investigators

• Study Director: AbbVie Inc.; AbbVie

• PRS Account: AbbVie
• Verification Date: December 2020