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Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01441635
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : July 15, 2020
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date  ICMJE September 6, 2011
First Posted Date  ICMJE September 28, 2011
Results First Submitted Date  ICMJE June 9, 2020
Results First Posted Date  ICMJE July 15, 2020
Last Update Posted Date July 15, 2020
Actual Study Start Date  ICMJE September 8, 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
Mean Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) [ Time Frame: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) ]
The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
  • Assessment of Bleeding [ Time Frame: Day 1 ]
    The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.
  • Assessment of Bleeding [ Time Frame: Month 3 ]
    The mean change from baseline to the last menstrual cycle during treatment in uterine blood loss.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2020)
  • Percent Change From Baseline to the Last 28 Days of Treatment in Menstrual Blood Loss (MBL) [ Time Frame: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) ]
    The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
  • Percentage of Participants With MBL < 80 mL and With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment [ Time Frame: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) ]
    The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
  • Percentage of Participants With MBL < 80 mL During the Last 28 Days of Treatment [ Time Frame: The last 28 days of treatment (approximately days 61 to 90) ]
    The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
  • Percentage of Participants With a ≥ 50% Reduction From Baseline in MBL During the Last 28 Days of Treatment [ Time Frame: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90) ]
    The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment. Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero.
  • Percentage of Participants With No Change, Decrease From Baseline, or Increase From Baseline in Hemoglobin at Month 3 [ Time Frame: Baseline and Month 3 ]
    The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories:
    • No change from baseline in hemoglobin
    • Decrease from baseline in hemoglobin ≥ -0.5 g/dL
    • Decrease from baseline in hemoglobin ≥ -1.0 g/dL
    • Increase from baseline in hemoglobin ≥ 0.5 g/dL
    • Increase from baseline in hemoglobin ≥ 1.0 g/dL
    The above categories are not all mutually exclusive or exhaustive.
  • Change in Hemoglobin Concentration From Baseline to Month 3 [ Time Frame: Baseline and Month 3 ]
  • Change From Baseline to Month 3 in Uterine Bleeding Score [ Time Frame: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90) ]
    Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
    • 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
    • 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
    • 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
    • 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
    • 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
    • 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
  • Change From Baseline to Month 3 in Percentage of Days With Any Uterine Bleeding [ Time Frame: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90) ]
    Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
    • 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
    • 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
    • 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
    • 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
    • 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
    • 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
    A day with any uterine bleeding is defined as a days with a bleeding score ≥ 1.
  • Change From Baseline to Month 3 in Percentage of Days With Moderate to Very Heavy Bleeding [ Time Frame: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90) ]
    Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
    • 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
    • 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
    • 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
    • 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
    • 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
    • 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
    A day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3.
  • Percentage of Participants With Any Uterine Bleeding or Moderate to Very Heavy Uterine Bleeding at Month 3 [ Time Frame: Month 3 (average bleeding score over days 61 to 90) ]
    Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:
    • 1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.
    • 2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.
    • 3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.
    • 4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.
    • 5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.
    • 6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.
    Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3.
  • Percentage of Participants With Suppression of Bleeding (Spotting Allowed) or Amenorrhea During the Last 56 Days of Treatment [ Time Frame: The last 56 days of treatment (approximately days 33 to 90) ]
    Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment. Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment.
  • Percent Change From Baseline to Month 3 in Uterine Volume [ Time Frame: Baseline and month 3 ]
    Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
  • Percentage of Participants With ≥ 25% Reduction in Uterine Volume at Month 3 / Final Visit [ Time Frame: Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued. ]
    Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
  • Percent Change From Baseline to Month 3 in Volume of the Largest Fibroid [ Time Frame: Baseline and month 3 ]
    The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
  • Percentage of Participants With ≥ 25% Reduction in Volume of Largest Fibroid at Month 3 / Final Visit [ Time Frame: Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued. ]
    The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center.
  • Change From Baseline to Month 3 in the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QoL) [ Time Frame: Baseline and month 3 ]
    The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from "not at all" to "a very great deal" for symptom severity items and "none of the time" to "all of the time" for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components. Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life.
  • Change From Baseline to Month 3 in the Uterine Fibroids Daily Symptom Scale Scores [ Time Frame: Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90) ]
    The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary.
  • Change From Baseline to Month 3 in the Subject Surgery Intention Questionnaire (SSIQ) Version 2.0 [ Time Frame: Baseline and month 3 ]
    The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery). SSIQ included the 2 following questions:
    1. How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now?
    2. How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?
  • Change From Baseline to Month 3 in the Physician Surgery Intention Questionnaire (PSIQ) Version 2.0 [ Time Frame: Baseline and month 3 ]
    The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery). The PSIQ included the 2 following questions:
    1. How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now?
    2. How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
  • Number of Bleeding Days [ Time Frame: Day 1 ]
    Change from baseline to Month 3 in Number of Bleeding Days
  • Number of Bleeding Days [ Time Frame: Month 3 ]
    Change from baseline to Month 3 in Number of Bleeding Days
  • Menstrual Bleeding Scores [ Time Frame: Day 1 ]
    Change from baseline to Month 3 in menstrual bleeding scores.
  • Menstrual Bleeding Scores [ Time Frame: Month 3 ]
    Change from baseline to Month 3 in menstrual bleeding scores.
  • Uterine Volume [ Time Frame: Day 1 ]
    Percent change from baseline to Month 3 in uterine volume
  • Uterine Volume [ Time Frame: Month 3 ]
    Percent change from baseline to Month 3 in uterine volume
  • Hemoglobin Concentration [ Time Frame: Day 1 ]
    Change from baseline to Month 3 in hemoglobin concentration
  • Hemoglobin Concentration [ Time Frame: Month 3 ]
    Change from baseline to Month 3 in hemoglobin concentration
  • Safety Evaluation - Adverse event monitoring [ Time Frame: Up to month 9 ]
  • Safety Evaluation - Vital signs [ Time Frame: 2 months prior to dosing ]
    Temperature, Blood Pressure and Pulse
  • Safety Evaluation - Vital signs [ Time Frame: Day 1 ]
    Temperature, Blood Pressure and Pulse
  • Safety Evaluation - Vital signs [ Time Frame: Month 1 ]
    Temperature, Blood Pressure and Pulse
  • Safety Evaluation - Vital signs [ Time Frame: Month 2 ]
    Temperature, Blood Pressure and Pulse
  • Safety Evaluation - Vital signs [ Time Frame: Month 3 ]
    Temperature, Blood Pressure and Pulse
  • Safety Evaluation - Vital signs [ Time Frame: 3 Months Post Dosing ]
    Temperature, Blood Pressure and Pulse
  • Physical examinations (complete or symptom directed) [ Time Frame: 2 months prior to dosing ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Day 1 ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Month 1 ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Month 2 ]
  • Physical examinations (complete or symptom directed) [ Time Frame: Month 3 ]
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: 2 months prior to dosing ]
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: Day 1 ]
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: Month 3 ]
  • Bone Biomarkers [ Time Frame: Day 1 ]
    Osteocalcin, CTX, P1NP
  • Bone Biomarkers [ Time Frame: Month 3 ]
    Osteocalcin, CTX, P1NP
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Official Title  ICMJE Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids
Brief Summary The purpose of this proof-of-concept study is to assess the safety and effectiveness of elagolix versus placebo to reduce uterine bleeding associated with uterine fibroids, and to reduce fibroid volume and uterine volume in premenopausal women 20 to 49 years of age with heavy uterine bleeding.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heavy Uterine Bleeding
  • Uterine Fibroids
Intervention  ICMJE
  • Drug: Elagolix
    Elagolix tablets
    Other Name: ABT-620
  • Drug: Placebo
    Matching placebo tablets
  • Drug: Estradiol/Norethindrone acetate (E2/NETA)
    A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.
    Other Name: Activella®
  • Drug: Estradiol
    1.0 mg micronized estradiol tablets administered once a day
    Other Name: Estrace®
  • Drug: Progesterone
    Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle
    Other Name: Prometrium®
Study Arms  ICMJE
  • Experimental: Cohort 4 Elagolix 400 mg QD
    Participants received elagolix 400 mg once a day (QD) for 3 months.
    Intervention: Drug: Elagolix
  • Experimental: Cohort 4 Elagolix 100 mg BID
    Participants received elagolix 100 mg twice a day (BID) for 3 months.
    Intervention: Drug: Elagolix
  • Placebo Comparator: Cohort 4 Placebo
    Participants received placebo to elagolix BID for 3 months.
    Intervention: Drug: Placebo
  • Experimental: Cohort 1 Elagolix 200 mg BID
    Participants received elagolix 200 mg twice a day for 3 months.
    Intervention: Drug: Elagolix
  • Placebo Comparator: Cohort 1 Placebo
    Participants received placebo to elagolix twice a day for 3 months.
    Intervention: Drug: Placebo
  • Placebo Comparator: Cohort 3 Elagolix 200 mg BID + LD E2/NETA
    Participants received elagolix 200 mg twice a day plus continuous low-dose (LD) estradiol (E2) 0.5 mg/norethindrone acetate 0.1 mg (NETA) once a day for 3 months.
    Interventions:
    • Drug: Elagolix
    • Drug: Estradiol/Norethindrone acetate (E2/NETA)
  • Experimental: Cohort 5 Elagolix 600 mg QD
    Participants received elagolix 600 mg once a day for 3 months.
    Intervention: Drug: Elagolix
  • Experimental: Cohort 2 Elagolix 300 mg BID
    Participants received elagolix 300 mg twice a day for 3 months.
    Intervention: Drug: Elagolix
  • Experimental: Cohort 2 Placebo
    Participants received placebo to elagolix BID for 3 months.
    Intervention: Drug: Placebo
  • Experimental: Cohort 6 Elagolix 300 mg BID + CEP
    Participants received elagolix 300 mg twice a day plus cyclical estrogen/progesterone (CEP, consisting of estradiol 1 mg a day and progesterone 200 mg on days 17 to 28 of each 30-day treatment cycle) for 3 months.
    Interventions:
    • Drug: Elagolix
    • Drug: Estradiol
    • Drug: Progesterone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
271
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2011)
300
Actual Study Completion Date  ICMJE May 17, 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is a pre-menopausal female 20 to 49 years of age.
  • Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following criteria:

    • At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound.
    • Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary).
    • Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the inclusion requirements.
  • Subject has a history of regular menstrual cycles between 24 to 35 days.
  • Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method.

Exclusion Criteria:

  • Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation.
  • Subject has a history of osteoporosis or other metabolic bone disease.
  • Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes.
  • Subject has a history of clinically significant condition(s) including but not limited to:

    • Endometriosis
    • Epilepsy or seizures
    • Type 1 diabetes
    • Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT01441635
Other Study ID Numbers  ICMJE M12-663
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor  ICMJE AbbVie (prior sponsor, Abbott)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP