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Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus (SELECT-SLE)

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, SLE, Upadacitinib, Lupus

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE. At Screening, must have at least one of the following: antinuclear antibody (ANA) positive (titer >= 1:80) anti-double stranded deoxyribonucleic acid (dsDNA) positive anti-Smith positive Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently adjudicated at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as >= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present. Physician's Global Assessment (PhGA) >= 1 during screening period. On stable background treatment for >= 30 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for >=14 days prior to Baseline) with antimalarial(s) [hydroxychloroquine <= 400 mg daily, chloroquine <= 500 mg daily, quinacrine <= 100 mg daily]; and/or prednisone (or prednisone-equivalent) (<= 20 mg daily); and/or no more than 1 of the following: azathioprine (<= 150 mg daily), mycophenolate mofetil (<= 2 g daily), mycophenolate sodium <= 1,440 mg/day, leflunomide (<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (<= 23.7 mg twice daily), methotrexate (<= 25 mg weekly), or mizoribine (<=150 mg daily) Exclusion Criteria: Clinically relevant or significant ECG abnormalities at Screening. Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.

Sites / Locations

  • AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820Recruiting
  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824Recruiting
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 252831Recruiting
  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825Recruiting
  • Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828Recruiting
  • David S. Hallegua MD, A Professional Corporation /ID# 253902Recruiting
  • Wallace Rheumatic Studies Center, LLC /ID# 252806Recruiting
  • Providence Medical Foundation /ID# 252822Recruiting
  • Newport Huntington Medical Group /ID# 252827Recruiting
  • Millennium Clinical Trials /ID# 252817Recruiting
  • Denver Arthritis Clinic /ID# 253189Recruiting
  • Arthritis & Rheumatic Disease Specialties /ID# 253624Recruiting
  • HARAC Research Corp. /ID# 254922Recruiting
  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623Recruiting
  • Bay Area Arthritis and Osteo /ID# 253597Recruiting
  • Clinical Research of West Florida, Inc /ID# 253899Recruiting
  • Believe Clinical Trials /ID# 255427Recruiting
  • Omega Research Debary, LLC /ID# 254939Recruiting
  • Neoclinical Research /ID# 253614Recruiting
  • Jacksonville Center for Clinical Research /ID# 257272Recruiting
  • UF Health Rheumatology /ID# 255351Recruiting
  • Life Clinical Trials /ID# 253615Recruiting
  • Lakes Research, LLC /ID# 253621Recruiting
  • HMD Research LLC /ID# 253595Recruiting
  • Millennium Research /ID# 253600Recruiting
  • BayCare Medical Group /ID# 253593Recruiting
  • Clinical Research of West Florida - Tampa /ID# 253602Recruiting
  • BayCare Medical Group, Inc. /ID# 255135Recruiting
  • Atlanta Research Center for Rheumatology /ID# 253610Recruiting
  • Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 253018Recruiting
  • Greater Chicago Specialty Physicians /ID# 253021Recruiting
  • Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253020Recruiting
  • Deerbrook Medical Associates /ID# 253029Recruiting
  • AA Medical Research Center - Grand Blanc /ID# 253028Recruiting
  • June DO, PC /ID# 253030Recruiting
  • Kansas City Physician Partners /ID# 254786Recruiting
  • Logan Health Research /ID# 252808Recruiting
  • Arthritis and Osteo Assoc /ID# 252818Recruiting
  • DJL Clinical Research, PLLC /ID# 253620Recruiting
  • Accellacare - Salisbury /ID# 253608Recruiting
  • Wake Forest Baptist Health /ID# 254125Recruiting
  • Paramount Medical Research Con /ID# 253016Recruiting
  • Clinical Research Source, Inc. /ID# 253027Recruiting
  • Clinical Research of Philadelphia, LLC /ID# 254156Recruiting
  • West Tennessee Research Institute /ID# 252807Recruiting
  • Shelby Research /ID# 256937Recruiting
  • Arthritis and Rheumatology Research Institute, PLLC /ID# 253014Recruiting
  • JPS Rheumatology Clinic /ID# 253185Recruiting
  • Arthiritis and Rheumatology Specialists PA /ID# 255950Recruiting
  • R & H Clinical Research - 777 Katy /ID# 254126Recruiting
  • Valley Arthritis Center /ID# 253022Recruiting
  • Trinity Universal Research Associates, Inc /ID# 253013Recruiting
  • Sun Research Institute /ID# 255832Recruiting
  • DM Clinical Research - Tomball /ID# 255134Recruiting
  • Okayama University Hospital /ID# 253821Recruiting
  • University of Yamanashi Hospital /ID# 253264Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Study 1- Upadacitinib Dose A

Study 1- Placebo

Study 2- Upadacitinib Dose A

Study 2- Placebo

Study 3- Low Disease Activity Upadacitinib (LDA) Dose A

Study 3- Low Disease Activity Upadacitinib Dose B

Study 3- No LDA Upadacitinib Dose A

Study 3- Upadacitininb Dose A

Study 3- Open Label Upadacitinib Dose A

Study 3- Open Label Upadacitinib Dose B

Arm Description

Participants will receive upadacitinib dose A once daily for 52 weeks.

Participants will receive upadacitinib matching placebo once daily for 52 weeks.

Participants will receive upadacitinib dose A once daily for 52 weeks.

Participants will receive upadacitinib matching placebo once daily for 52 weeks.

Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.

Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.

Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.

Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.

Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.

Participants who reach >= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.

Secondary Outcome Measures

Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year)
Flare is defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic lupus erythematosus disease activity index (SLEDAI) Flare Index (SFI). An index defining Systemic lupus erythematosus (SLE) flares using changes in the Hybrid SLEDAI (hSLEDAI) score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Flare rate is number of flares per patient-year.
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
SRI is a composite responder index based on improvement in disease activity (number following SRI indicates numerical improvement in hSLEDAI score) without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group [BILAG] A or > 1 new BILAG B).
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
LLDAS is a state of low disease activity based on SLEDAI score (hSLEDAI score <= 4 excluding hSLEDAI 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.
Time to First Flare per SELENA SLEDAI Flare Index (SFI)
SFI is an index defining SLE flares using changes in the hSLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Percentage of Participants Achieving Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
Achievement of glucocorticoid dose <=7.5 mg/day prednisone-equivalent among participants taking >= 10 mg/day prednisone-equivalent at baseline.
Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
The Lupus Pain-NRS is a single-item questionnaire in which participants are asked to rate their overall pain level due to lupus over the last week. The Lupus Pain-NRS scores range from 0 to 10, with higher scores indicating a higher level of pain.
Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints
Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
The SF-36v2® Health Survey Acute is a general HRQoL instrument with extensive use in multiple disease states. The instrument comprises 36 total items (questions) targeting a participants's functional health and well-being in 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Scoring is totaled into a Physical Component Summary and a Mental Component Summary. Higher scores indicate a better state of health.
Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
CLASI index used to assess cutaneous manifestations of SLE summarizing the activity of the disease. Scores range from 0 to 70, with higher scores indicating more severity. Achievement of >= 50% reduction in CLASI activity score among participants with baseline score >=10.

Full Information

First Posted
April 25, 2023
Last Updated
October 23, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05843643
Brief Title
Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
Acronym
SELECT-SLE
Official Title
SELECT-SLE: A Phase 3 Program to Evaluate the Safety and Efficacy of Upadacitinib in Subjects With Moderately to Severely Active SLE
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2023 (Actual)
Primary Completion Date
October 2, 2026 (Anticipated)
Study Completion Date
October 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 3 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib based on their disease activity and their original treatment assignment in Study 1 or 2. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, SLE, Upadacitinib, Lupus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study 1- Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib dose A once daily for 52 weeks.
Arm Title
Study 1- Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Arm Title
Study 2- Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib dose A once daily for 52 weeks.
Arm Title
Study 2- Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive upadacitinib matching placebo once daily for 52 weeks.
Arm Title
Study 3- Low Disease Activity Upadacitinib (LDA) Dose A
Arm Type
Experimental
Arm Description
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose A once daily for 52 weeks.
Arm Title
Study 3- Low Disease Activity Upadacitinib Dose B
Arm Type
Experimental
Arm Description
Participants in the upadacitinib arms from Study 1 or Study 2 with LDA will receive upadacitinib dose B once daily for 52 weeks.
Arm Title
Study 3- No LDA Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants in the upadacitinib arms from Study 1 or Study 2 with no LDA will receive upadacitinib dose A once daily for 52 weeks.
Arm Title
Study 3- Upadacitininb Dose A
Arm Type
Experimental
Arm Description
Participants in the placebo arms of Study 1 or Study 2 will receive upadacitinib Dose A once daily for 52 weeks.
Arm Title
Study 3- Open Label Upadacitinib Dose A
Arm Type
Experimental
Arm Description
Participants who experience a suspected systemic lupus erythematosus (SLE) flare may receive open label upadacitinib Dose A once daily for the remainder of the study.
Arm Title
Study 3- Open Label Upadacitinib Dose B
Arm Type
Experimental
Arm Description
Participants who reach >= 65 years of age and are still on study drug may receive open-label upadacitinib Dose B once daily, and participants who experience a suspected SLE flare while on upadacitinib Dose B may receive upadacitinib Dose A for the remainder of the study.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving British Isles Lupus Assessment Group Based Combined Lupus Assessment (BICLA) Response
Description
BICLA is a composite responder index based on improvement in organ systems without worsening of the overall condition and improvement in disease activity.
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Percentage of Flares Participants Experiencing Over Time (Number of Flares Per Patient-Year)
Description
Flare is defined by the Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) Systemic lupus erythematosus disease activity index (SLEDAI) Flare Index (SFI). An index defining Systemic lupus erythematosus (SLE) flares using changes in the Hybrid SLEDAI (hSLEDAI) score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity. Flare rate is number of flares per patient-year.
Time Frame
Week 52
Title
Percentage of Participants Achieving Systemic Lupus Erythematosus Responder Index (SRI) -4
Description
SRI is a composite responder index based on improvement in disease activity (number following SRI indicates numerical improvement in hSLEDAI score) without worsening of the overall condition (no worsening in Physician's Global Assessment (PhGA), < 0.3 point increase) or the development of significant disease activity in new organ systems (no new British Isles Lupus Assessment Group [BILAG] A or > 1 new BILAG B).
Time Frame
At Week 52
Title
Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS)
Description
LLDAS is a state of low disease activity based on SLEDAI score (hSLEDAI score <= 4 excluding hSLEDAI 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.
Time Frame
At Week 52
Title
Time to First Flare per SELENA SLEDAI Flare Index (SFI)
Description
SFI is an index defining SLE flares using changes in the hSLEDAI score, definitions of worsening signs and symptoms, treatment changes, and Physician's Global Assessment of Disease Activity.
Time Frame
Week 52
Title
Percentage of Participants Achieving Glucocorticoid Dose <=7.5 mg/day Prednisone-Equivalent
Description
Achievement of glucocorticoid dose <=7.5 mg/day prednisone-equivalent among participants taking >= 10 mg/day prednisone-equivalent at baseline.
Time Frame
From Week 44 to Week 52
Title
Change from Baseline in Lupus Pain Numerical Rating Scale (NRS)
Description
The Lupus Pain-NRS is a single-item questionnaire in which participants are asked to rate their overall pain level due to lupus over the last week. The Lupus Pain-NRS scores range from 0 to 10, with higher scores indicating a higher level of pain.
Time Frame
Baseline to Week 28
Title
Percentage of Participants Achieving >= 50% Improvement in Tender or Swollen Joints
Description
Achievement of >= 50% improvement in tender or swollen joints among participants with >= 3 swollen joints and >= 6 total affected joints at Baseline.
Time Frame
Week 52
Title
Change from Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Version 4
Description
The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants. Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.
Time Frame
Baseline to Week 28
Title
Change from Baseline in 36-Item Short Form Health Survey (SF-36) Acute Physical Component Summary (PCS)
Description
The SF-36v2® Health Survey Acute is a general HRQoL instrument with extensive use in multiple disease states. The instrument comprises 36 total items (questions) targeting a participants's functional health and well-being in 8 dimensions (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Scoring is totaled into a Physical Component Summary and a Mental Component Summary. Higher scores indicate a better state of health.
Time Frame
Baseline to Week 28
Title
Percentage of Participants Achieving >= 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
Description
CLASI index used to assess cutaneous manifestations of SLE summarizing the activity of the disease. Scores range from 0 to 70, with higher scores indicating more severity. Achievement of >= 50% reduction in CLASI activity score among participants with baseline score >=10.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of systemic lupus erythematosus (SLE) at least 24 weeks prior to screening as defined by the 2019 European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) classification criteria for SLE. At Screening, must have at least one of the following: antinuclear antibody (ANA) positive (titer >= 1:80) anti-double stranded deoxyribonucleic acid (dsDNA) positive anti-Smith positive Hybrid systemic lupus erythematosus disease activity index (hSLEDAI) >= 6, of which >= 4 points are clinical (not based on laboratory criteria), independently adjudicated at Screening. Clinical hSLEDAI score (not based on laboratory criteria) must be re-confirmed as >= 4 at the Baseline visit. Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility but should be documented on the hSLEDAI if present. Physician's Global Assessment (PhGA) >= 1 during screening period. On stable background treatment for >= 30 days prior to Baseline (with the exception of oral corticosteroid [OCS], which must be at a stable dose for >=14 days prior to Baseline) with antimalarial(s) [hydroxychloroquine <= 400 mg daily, chloroquine <= 500 mg daily, quinacrine <= 100 mg daily]; and/or prednisone (or prednisone-equivalent) (<= 20 mg daily); and/or no more than 1 of the following: azathioprine (<= 150 mg daily), mycophenolate mofetil (<= 2 g daily), mycophenolate sodium <= 1,440 mg/day, leflunomide (<= 20 mg daily), cyclosporine, tacrolimus, voclosporin (<= 23.7 mg twice daily), methotrexate (<= 25 mg weekly), or mizoribine (<=150 mg daily) Exclusion Criteria: Clinically relevant or significant ECG abnormalities at Screening. Planned elective surgery that would impact study procedures or assessments through the completion of the Week 52 assessments.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001-6299
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297-7336
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306-9802
Country
United States
Individual Site Status
Recruiting
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 252831
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
David S. Hallegua MD, A Professional Corporation /ID# 253902
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Wallace Rheumatic Studies Center, LLC /ID# 252806
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation /ID# 252822
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Individual Site Status
Recruiting
Facility Name
Newport Huntington Medical Group /ID# 252827
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648-5994
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Clinical Trials /ID# 252817
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-3951
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
805-496-3322
Facility Name
Denver Arthritis Clinic /ID# 253189
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis & Rheumatic Disease Specialties /ID# 253624
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
305-932-4162
Facility Name
HARAC Research Corp. /ID# 254922
City
Avon Park
State/Province
Florida
ZIP/Postal Code
33825-2958
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253623
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
561-361-6547
Facility Name
Bay Area Arthritis and Osteo /ID# 253597
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
813-651-4441
Facility Name
Clinical Research of West Florida, Inc /ID# 253899
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
727-466-0078
Facility Name
Believe Clinical Trials /ID# 255427
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
954 341 5034
Facility Name
Omega Research Debary, LLC /ID# 254939
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Individual Site Status
Recruiting
Facility Name
Neoclinical Research /ID# 253614
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1897
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
1-305-456-9062
Facility Name
Jacksonville Center for Clinical Research /ID# 257272
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Individual Site Status
Recruiting
Facility Name
UF Health Rheumatology /ID# 255351
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
904-633-0071
Facility Name
Life Clinical Trials /ID# 253615
City
Margate
State/Province
Florida
ZIP/Postal Code
33063-5704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
954-669-1052
Facility Name
Lakes Research, LLC /ID# 253621
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
HMD Research LLC /ID# 253595
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Research /ID# 253600
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
BayCare Medical Group /ID# 253593
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
727-824-3147
Facility Name
Clinical Research of West Florida - Tampa /ID# 253602
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-1246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
813-870-1292
Facility Name
BayCare Medical Group, Inc. /ID# 255135
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
813-840-3600
Facility Name
Atlanta Research Center for Rheumatology /ID# 253610
City
Marietta
State/Province
Georgia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Recruiting
Facility Name
Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 253018
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521-3186
Country
United States
Individual Site Status
Recruiting
Facility Name
Greater Chicago Specialty Physicians /ID# 253021
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60195-3106
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253020
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
Deerbrook Medical Associates /ID# 253029
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
847-984-6454
Facility Name
AA Medical Research Center - Grand Blanc /ID# 253028
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Name
June DO, PC /ID# 253030
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas City Physician Partners /ID# 254786
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64151
Country
United States
Individual Site Status
Recruiting
Facility Name
Logan Health Research /ID# 252808
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
406-755-1460
Facility Name
Arthritis and Osteo Assoc /ID# 252818
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
575-571-7529
Facility Name
DJL Clinical Research, PLLC /ID# 253620
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare - Salisbury /ID# 253608
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144-2735
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
7046479913
Facility Name
Wake Forest Baptist Health /ID# 254125
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
336-713-4379
Facility Name
Paramount Medical Research Con /ID# 253016
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Source, Inc. /ID# 253027
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Philadelphia, LLC /ID# 254156
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Name
West Tennessee Research Institute /ID# 252807
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
731-664-0002
Facility Name
Shelby Research /ID# 256937
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Rheumatology Research Institute, PLLC /ID# 253014
City
Allen
State/Province
Texas
ZIP/Postal Code
75013-6147
Country
United States
Individual Site Status
Recruiting
Facility Name
JPS Rheumatology Clinic /ID# 253185
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-4917
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthiritis and Rheumatology Specialists PA /ID# 255950
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
940-626-8073
Facility Name
R & H Clinical Research - 777 Katy /ID# 254126
City
Katy
State/Province
Texas
ZIP/Postal Code
77450-2244
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Arthritis Center /ID# 253022
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501-1401
Country
United States
Individual Site Status
Recruiting
Facility Name
Trinity Universal Research Associates, Inc /ID# 253013
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
214-793-8341
Facility Name
Sun Research Institute /ID# 255832
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
210-227-1289
Facility Name
DM Clinical Research - Tomball /ID# 255134
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital /ID# 253821
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Yamanashi Hospital /ID# 253264
City
Chuo-shi
State/Province
Yamanashi
ZIP/Postal Code
409-3821
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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, 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.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing 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 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/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M23-699
Description
Related Info

Learn more about this trial

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

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