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A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease

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: NCT03105128
Recruitment Status : Completed
First Posted : April 7, 2017
Results First Posted : July 6, 2022
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE April 4, 2017
First Posted Date  ICMJE April 7, 2017
Results First Submitted Date  ICMJE March 31, 2022
Results First Posted Date  ICMJE July 6, 2022
Last Update Posted Date July 6, 2022
Actual Study Start Date  ICMJE May 10, 2017
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2022)
  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 12 ]
    The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
  • US Specific: Percentage of Participants With Endoscopic Response [ Time Frame: Week 12 ]
    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
  • Global Outside of US: Percentage of Participants With Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
  • Global Outside of US: Percentage of Participants With Endoscopic Response [ Time Frame: Week 12 ]
    The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • Percentage of participants with clinical remission per daily stool frequency (SF) and average daily abdominal pain (AP) score at Week 12 [ Time Frame: Week 12 ]
    Clinical remission per average daily SF and average daily AP score.
  • Percentage of participants with endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Endoscopic response defined as decrease from Baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2022)
  • US Specific: Percentage of Participants With Clinical Remission [ Time Frame: Week 12 ]
    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Week 4 ]
    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Week 12 ]
    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
  • US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: Week 12 ]
    The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
  • US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 4 ]
    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
  • US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response [ Time Frame: Week 12 ]
    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline. Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
  • US Specific: Percentage of Participants With Stool Frequency (SF) Remission [ Time Frame: Week 12 ]
    Stool Frequency (SF) remission is defined as an average daily SF <= 2.8 and not worse than baseline.
  • US Specific: Percentage of Participants With Abdominal Pain (AP) Remission [ Time Frame: Week 12 ]
    The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score <= 1 and not worse than baseline.
  • US Specific: Percentage of Participants With Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
  • US Specific: Percentage of Participants With Enhanced Clinical Response [ Time Frame: Week 4 ]
    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
  • US Specific: Percentage of Participants With Ulcer-Free Endoscopy [ Time Frame: Week 12 ]
    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
  • US Specific: Percentage of Participants With Enhanced Clinical Response [ Time Frame: Week 12 ]
    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
  • US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at [ Time Frame: Week 12 ]
    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
  • US Specific: Percentage of Participants With CD-Related Hospitalization [ Time Frame: Week 12 ]
    Participants with at least one admission to the hospital due to Crohn's Disease.
  • US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline [ Time Frame: Week 12 ]
    Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
  • Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission [ Time Frame: Week 12 ]
    The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI < 150.
  • Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Week 4 ]
    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
  • Global Outside of US: Percentage of Participants With Clinical Remission [ Time Frame: Week 4 ]
    Clinical remission is defined as using the average daily Stool Frequency (SF) ≤ 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score ≤ 1 and not worse than Baseline.
  • Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response [ Time Frame: Week 12 ]
    Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI ≥ 100 points from baseline.
  • Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue [ Time Frame: Week 12 ]
    The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
  • Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score [ Time Frame: Week 12 ]
    The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
  • Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response [ Time Frame: Week 12 ]
    Enhanced clinical response was defined as ≥ 60% decrease in average daily Stool Frequency and/or ≥ 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
  • Global Outside of US: Percentage of Participants With Endoscopic Remission [ Time Frame: Week 12 ]
    Endoscopic remission: SES-CD ≤ 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
  • Global Outside of US: Percentage of Participants With Enhanced Clinical Response [ Time Frame: Week 4 ]
    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
  • Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy [ Time Frame: Week 12 ]
    Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore ≥ 1 at Baseline
  • Global Outside of US: Percentage of Participants With Enhanced Clinical Response [ Time Frame: Week 12 ]
    Enhanced clinical response: ≥ 60% decrease in average daily SF and/or ≥ 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
  • Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline [ Time Frame: Week 12 ]
    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
  • Global Outside of US: Percentage of Participants With CD-Related Hospitalization [ Time Frame: Week 12 ]
    Participants with at least one admission to the hospital due to Crohn's Disease.
  • Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline [ Time Frame: Week 12 ]
    Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
  • Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment [ Time Frame: Week 12 ]
    WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
  • Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score [ Time Frame: Week 12 ]
    The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • Percentage of participants with enhanced clinical response at Week 4 [ Time Frame: Week 4 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
  • Percentage of participants with clinical remission per Crohn's Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 12 ]
    The CDAI is used to evaluate disease activity in patients with Crohn's disease.
  • Percentage of participants with enhanced clinical response at Week 12 [ Time Frame: Week 12 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score.
  • Percentage of participants with clinical remission per average daily SF and average daily AP score at Week 4 [ Time Frame: Week 4 ]
    Clinical remission per average daily SF and average daily AP score.
  • Percentage of participants with enhanced clinical response and endoscopic response at Week 12 [ Time Frame: Week 12 ]
    Enhanced clinical response defined as decrease in average daily SF and/or decrease in average daily AP score, and/or clinical remission per average daily SF and average daily AP score. Endoscopic response defined as decrease from Baseline in SES-CD.
  • Percentage of participants with endoscopic healing at Week 12 [ Time Frame: Week 12 ]
    Endoscopic healing was assessed using SES-CD.
  • Crohn's Symptom Severity (CSS): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The CSS is a patient questionnaire to assess severity of Crohn's symptoms.
  • Percentage of participants with resolution of extra-intestinal manifestations (EIMs) at Week 12, in subjects with EIMs at Baseline [ Time Frame: Week 12 ]
    Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
  • Percentage of participants with hospitalization through Week 12 [ Time Frame: 12 weeks ]
    Participants with an event that results in admission to the hospital.
  • Percentage of participants with draining fistulas at Week 12 in participants with draining fistulas at Baseline [ Time Frame: Baseline, Week 12 ]
    Participants with draining fistulas at Week 12 in participants who had draining fistulas at baseline.
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
  • 36-Item Short Form Health Status Survey (SF-36): Change from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ]
    The SF-36 is an indicator of overall health status.
  • Percentage of participants with Crohn's disease (CD)-related surgeries through Week 12 [ Time Frame: 12 weeks ]
    Participants who underwent surgery related to CD.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease
Brief Summary The purpose of this study is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active Crohn's disease (CD).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: placebo for risankizumab
    Placebo for risankizumab administered by intravenous infusion
  • Drug: risankizumab IV
    Risankizumab administered by intravenous infusion
    Other Names:
    • ABBV-066 BI 655066
    • SKYRIZI
  • Drug: risankizumab SC
    Risankizumab administered by subcutaneous (SC) injection
    Other Names:
    • ABBV-066 BI 655066
    • SKYRIZI
Study Arms  ICMJE
  • Experimental: Risankizumab Dose 1 (Period 1)
    Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Experimental: Risankizumab Dose 2 (Period 1)
    Participants randomized to receive risankizumab dose 2 administered by intravenous (IV) infusion.
    Intervention: Drug: risankizumab IV
  • Placebo Comparator: Placebo (Period 1)
    Participants randomized to receive placebo for risankizumab administered by intravenous (IV) infusion.
    Intervention: Drug: placebo for risankizumab
  • Experimental: Risankizumab Dose 1 (Period 2)
    Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.
    Intervention: Drug: risankizumab IV
  • Experimental: Risankizumab Dose 2 (Period 2)
    Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
    Intervention: Drug: risankizumab SC
  • Experimental: Risankizumab Dose 3 (Period 2)
    Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.
    Intervention: Drug: risankizumab SC
Publications * D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panés J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.

*   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: March 3, 2021)
931
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2017)
940
Actual Study Completion Date  ICMJE April 14, 2021
Actual Primary Completion Date November 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
  • Diagnosis of CD for at least 3 months prior to Baseline.
  • Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
  • Demonstrated intolerance or inadequate response to conventional or to biologic therapy for CD.
  • If female, participant must meet the contraception recommendations.

Exclusion Criteria:

  • Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
  • Participants with unstable doses of concomitant Crohn's disease therapy.
  • Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within 35 days or 5 half-lives prior to Baseline, whichever is longer.
  • Prior exposure to p19 inhibitors (e.g., risankizumab).
  • Complications of Crohn's disease.
  • Having an ostomy or ileoanal pouch.
  • Known active Coronavirus Disease 2019 (COVID-19) infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czechia,   Estonia,   Germany,   Greece,   Hong Kong,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom,   United States
Removed Location Countries Finland,   France,   Hungary,   Turkey
 
Administrative Information
NCT Number  ICMJE NCT03105128
Other Study ID Numbers  ICMJE M16-006
2016-003123-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
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)
Time Frame: For details on when studies are available for sharing, please refer to the link below.
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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbbVie
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date June 2022

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