GRACE: Real-World Experience Study of Elagolix For the Treatment of Endometriosis in Canada
Study Details
Study Description
Brief Summary
The objective of this study is to evaluate real-world effectiveness of elagolix in Canadian women with endometriosis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with endometriosis Premenopausal participants with endometriosis receiving elagolix in real-world setting |
Outcome Measures
Primary Outcome Measures
- Change in Dysmenorrhea Score [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
Secondary Outcome Measures
- Percentage of Participants With Patient Global Impression of Change (PGIC) Response [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 [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) [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 [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 [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 [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 [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) [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 [Up to approximately 18 months]
Percentage of participants using concomitant medications/treatments is assessed.
- Percentage of Participants Using Other Medications/Treatments [Up to approximately 18 months]
Percentage of participants using other medications/treatments for endometriosis is assessed.
- Percentage of Participants Using Pain/Rescue Medications [Up to approximately 18 months]
Percentage of participants using pain/rescue medications is assessed.
- Percentage of Participants Using Add-Back [Up to approximately 18 months]
Percentage of participants with use of add-back is reported
- Change from Baseline in Endometrial Health Profile (EHP)-30 [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 [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) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Prescribed elagolix as part of standard treatment
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Naive to elagolix prior to starting this study or have stopped taking elagolix for 2 months prior to the start of this study
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Symptomatic endometriosis (clinically or surgically diagnosed) including currently experiencing dysmenorrhea
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Has provided written informed consent allowing the use of their data for the study
Exclusion Criteria:
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Did not consent
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Cannot fill out questionnaires
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Prescribed elagolix for a period of 1 or 2 months only
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Post-menopausal (naturally or surgically)
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Symptomatic uterine fibroid(s)
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Had medical treatment for uterine fibroids (any length of treatment)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | South Health Campus Rheumatology Clinic /ID# 213065 | Calgary | Alberta | Canada | T3M 1M4 |
| 2 | Aubrey D. Uretsky Professional Corporation /ID# 214753 | Edmonton | Alberta | Canada | T5T 1L6 |
| 3 | BC Women's Hospital /ID# 214561 | Vancouver | British Columbia | Canada | V6H 2N9 |
| 4 | Strand Clinic /ID# 213567 | St. John's | Newfoundland and Labrador | Canada | A1A 4Y3 |
| 5 | IWK Health Center /ID# 213066 | Halifax | Nova Scotia | Canada | B3K 6R8 |
| 6 | Hamilton Health Sciences - McMaster University Medical Centre /ID# 213496 | Hamilton | Ontario | Canada | L8S 4K1 |
| 7 | Dr. George A. Vilos Medicine Professional Corporation /ID# 214497 | London | Ontario | Canada | N5X 2N7 |
| 8 | Ottawa Hospital Research Institute /ID# 213608 | Ottawa | Ontario | Canada | K1H 8L6 |
| 9 | Medicor Research Inc /ID# 213467 | Sudbury | Ontario | Canada | P3A 1W8 |
| 10 | Sunnybrook Health Sciences Ctr /ID# 214330 | Toronto | Ontario | Canada | M4N 3M5 |
| 11 | Unity Health Toronto - St. Michael's Hospital /ID# 213590 | Toronto | Ontario | Canada | M5B 1W8 |
| 12 | CISSS - Hôpital de Gatineau /ID# 212944 | Gatineau | Quebec | Canada | J8P 7H2 |
| 13 | Jessima R&D Inc. /ID# 212943 | Lasalle | Quebec | Canada | H8N 1T9 |
| 14 | Clinique de Gynecologie-Obstetrique Pierre Boucher /ID# 213064 | Longueuil | Quebec | Canada | J4N 1C2 |
| 15 | CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 213439 | Montreal | Quebec | Canada | H1T 2M4 |
| 16 | Jewish General Hospital /ID# 215728 | Montreal | Quebec | Canada | H3T 1E2 |
| 17 | Duplicate_Brunswick Medical /ID# 214743 | Montréal | Quebec | Canada | H4A 3T2 |
| 18 | CHU de Quebec-Université Laval hôpital CHUL /ID# 213677 | Québec | Quebec | Canada | G1V 4G2 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: ABBVIE INC., AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- P19-933