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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03978520
Registration number
NCT03978520
Ethics application status
Date submitted
3/06/2019
Date registered
7/06/2019
Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
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Scientific title
A Phase 2 Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination (ABBV-599 Combination) in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus
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Secondary ID [1]
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2019-000638-20
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Secondary ID [2]
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M19-130
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Universal Trial Number (UTN)
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Trial acronym
SLEek
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Systemic Lupus Erythematosus (SLE)
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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Elsubrutinib
Treatment: Drugs - Placebo for elsubrutinib
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo for upadacitinib
Placebo comparator: Elsubrutinib placebo/upadacitinib placebo - Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 48 weeks
Experimental: ABBV-599 High Dose (Elsubrutinib 60 mg/upadacitinib 30 mg) - 60 mg elsubrutinib capsule once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
Experimental: Elsubrutinib placebo/upadacitinib 30 mg - Placebo capsule for elsubrutinib once a day by mouth for up to 48 weeks; 30 mg upadacitinib film-coated tablet once a day by mouth for up to 48 weeks
Experimental: ABBV-599 Low Dose (Elsubrutinib 60 mg/upadacitinib 15 mg) - 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; 15 mg upadacitinib film-coated tablet once a day by mouth for up to 24 weeks
Experimental: Elsubrutinib 60 mg/upadacitinib placebo - 60 mg elsubrutinib capsule once a day by mouth for up to 24 weeks; placebo film-coated tablet for upadacitinib once a day by mouth for up to 24 weeks
Treatment: Drugs: Elsubrutinib
Capsule; Oral
Treatment: Drugs: Placebo for elsubrutinib
Capsule; Oral
Treatment: Drugs: Upadacitinib
Film-coated tablet; Oral
Treatment: Drugs: Placebo for upadacitinib
Film-coated tablet; Oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving SLE Responder Index (SRI)-4 and Steroid Dose = 10 mg Prednisone Equivalent Once a Day (QD) at Week 24
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Assessment method [1]
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SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:
* = 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
* No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\])
* No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [1]
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Percentage of Participants Achieving SLE Responder Index (SRI)-4 at Week 24
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Assessment method [1]
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SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline:
* = 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score
* No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\])
* No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores (i.e., no organ system changes from baseline B/C/D/E to A and no more than 1 organ system changes from baseline C/D/E to B). A letter score is assigned to each organ system with following indications: A = severe, B = moderate, C = mild, D = inactive with prior history, and E = inactive with no history.
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Timepoint [1]
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Baseline, Week 24
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Secondary outcome [2]
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Percentage of Participants Achieving British Isles Lupus Assessment Group (BILAG) Based Combined Lupus Assessment (BICLA) Response at Week 24
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Assessment method [2]
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BICLA is a composite responder index. Achievement of BICLA response is defined as improvement in all initial A and B BILAG scores, with no more than one new BILAG B score without worsening of the overall condition (no worsening in Physician's Global Assessment \[PhGA\], \< 0.3 point increase) and no worsening of the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score.
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Timepoint [2]
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Baseline, Week 24
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Secondary outcome [3]
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Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 24
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Assessment method [3]
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LLDAS is a state of low disease activity based on Systemic Lupus Erythematosus Disease Activity Index 2000 score (SLEDAI-2K score =4 excluding SLEDAI-2K activity in major organ systems), absence of SLE disease activity in major organ systems and new disease activity, Physician's Global Assessment (PhGA =1), and concomitant medication usage (steroid dose =7.5 mg QD and toleration of immunosuppressive drugs at standard maintenance doses).
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Timepoint [3]
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Baseline, Week 24
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Secondary outcome [4]
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Change From Baseline in Daily Prednisone Dose at Week 24
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Assessment method [4]
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Participants' current use of steroid therapy was assessed at each study visit, and the amount of daily prednisone was documented.
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Timepoint [4]
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From Baseline to Week 24
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Secondary outcome [5]
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Number of Flares Per Patient-year by Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) SLEDAI Flare Index Through Week 24
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Assessment method [5]
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The SELENA SLEDAI flare index defines mild/moderate or severe SLE flares using the SLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
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Timepoint [5]
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From Baseline to Week 24
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Eligibility
Key inclusion criteria
* Participant has clinical diagnosis of Systemic Lupus Erythematosus (SLE) at least 24 weeks prior to Screening, meeting at least 4 of the 11 revised Criteria for Classification of SLE according to the 1997 Update of the 1982 American College of Rheumatology (ACR) OR meeting at least 4 of the 2012 SLICC classification criteria, including at least 1 clinical criterion and 1 immunologic criterion.
* At Screening, must have at least one of the following:
* antinuclear antibody (ANA)+ (titer = 1:80)
* anti-dsDNA+
* anti-Smith+
* SLEDAI-2K (SLE Disease Activity Index) = 6 despite background therapy as reported and independently adjudicated (clinical score = 4, excluding lupus headache and/or organic brain syndrome) at Screening:
* If 4 points of the required entry points are for arthritis, there must also be a minimum of 3 tender and 3 swollen joints.
* If participant has rash and Principal Investigator (PI) considers it to be attributable to SLE, participant must consent to skin photograph collection for adjudication.
* Score must be re-confirmed at the Baseline visit.
* Physician's Global Assessment (PhGA) = 1 during screening period.
* Must be on background treatment, stable for 30 days prior to Baseline and throughout the study with antimalarial(s), prednisone (or prednisone equivalent) (= 20 mg), azathioprine (= 150 mg), mycophenolate (<2 g), leflunomide (= 20 mg), cyclosporine, tacrolimus, and/or methotrexate (MTX) (= 20 mg).
* No combinations of the above with immunomodulators other than prednisone (or equivalents) and antimalarials.
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant using intravenous (IV) or intramuscular (IM) corticosteroids greater than or equal to a 40 mg prednisone-equivalent bolus within 30 days of planned randomization.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/07/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/07/2022
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Sample size
Target
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Accrual to date
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Final
341
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Emeritus Research Sydney /ID# 222983 - Botany
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Royal North Shore Hospital /ID# 222982 - St Leonards
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Royal Brisbane and Women's Hospital /ID# 212667 - Herston
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Rheumatology Research Unit Sunshine Coast /ID# 211902 - Maroochydore
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Griffith University /ID# 223543 - Southport
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The Queen Elizabeth Hospital /ID# 211901 - Woodville South
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Emeritus Research /ID# 211903 - Camberwell
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Monash Medical Centre /ID# 212313 - Clayton
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St Vincent's Hospital Melbourne /ID# 212311 - Fitzroy Melbourne
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Recruitment postcode(s) [1]
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2019 - Botany
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2065 - St Leonards
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4029 - Herston
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4558 - Maroochydore
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4222 - Southport
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5011 - Woodville South
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3124 - Camberwell
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Recruitment postcode(s) [8]
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3168 - Clayton
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Recruitment postcode(s) [9]
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3065 - Fitzroy Melbourne
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Recruitment outside Australia
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Spain
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State/province [99]
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Valencia
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Taiwan
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Taichung City
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Taiwan
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State/province [101]
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Taichung
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Country [102]
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Taiwan
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State/province [102]
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Taipei City
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Country [103]
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Taiwan
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State/province [103]
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Taoyuan City
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United Kingdom
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State/province [104]
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London, City Of
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United Kingdom
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Cambridge
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Ethics approval
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Summary
Brief summary
The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.
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Trial website
https://clinicaltrials.gov/study/NCT03978520
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Trial related presentations / publications
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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, analyses plans, 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 document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/20/NCT03978520/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/20/NCT03978520/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03978520