search
Back to results

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis (SELECT- SWITCH)

Primary Purpose

Rheumatoid Arthritis

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

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, Upadacitinib, Adalimumab, Methotrexate, MTX, TNF Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA. Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (originator or biosimilar) for RA (except adalimumab [originator or biosimilar]), but continue to exhibit active RA, or had to discontinue due to intolerability, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll. On oral or parenteral methotrexate (MTX) therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation. For participants in China, Japan, Korea, or Taiwan, a stable dose of MTX >= 7.5 mg/week is acceptable. Additional local requirements for MTX may apply. Meets both of the following disease activity criteria: >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline; High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L) at screening. Exclusion Criteria: History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA). Prior exposure to any janus kinase (JAK) inhibitor. Prior exposure to adalimumab (original or biosimilar). Prior exposure to a non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD).

Sites / Locations

  • AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 253431Recruiting
  • Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018Recruiting
  • Sun Valley Arthritis Center Ltd. /ID# 254654Recruiting
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 253432Recruiting
  • AZ Arthritis and Rheumotology Research, PLLC /ID# 255021Recruiting
  • Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017Recruiting
  • Arthritis and Rheumatism Associates /ID# 254013Recruiting
  • Newport Huntington Medical Group /ID# 252687Recruiting
  • Purushotham & Akther Kotha MD, Inc /ID# 252704Recruiting
  • Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692Recruiting
  • Rheumatology Center of San Diego /ID# 255038Recruiting
  • Millennium Clinical Trials /ID# 252689Recruiting
  • Comprehensive Rheumatology Center /ID# 252688Recruiting
  • Denver Arthritis Clinic /ID# 254058Recruiting
  • Tekton Research /ID# 255036Recruiting
  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733Recruiting
  • Bay Area Arthritis and Osteo /ID# 254046Recruiting
  • Clinical Research of West Florida, Inc /ID# 254649Recruiting
  • Omega Research Debary, LLC /ID# 253735Recruiting
  • Neoclinical Research /ID# 254622Recruiting
  • Life Clinical Trials /ID# 256061Recruiting
  • Lakes Research, LLC /ID# 255023Recruiting
  • HMD Research LLC /ID# 253732Recruiting
  • Millennium Research /ID# 253744Recruiting
  • BayCare Medical Group /ID# 253799Recruiting
  • Clinical Research of West Florida - Tampa /ID# 255264Recruiting
  • BayCare Medical Group, Inc. /ID# 255268Recruiting
  • Atlanta Research Center for Rheumatology /ID# 254623Recruiting
  • Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 254712Recruiting
  • Greater Chicago Specialty Physicians /ID# 254000Recruiting
  • Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 253999Recruiting
  • Deerbrook Medical Associates /ID# 254008Recruiting
  • Qualmedica Research - Evansville /ID# 254005Recruiting
  • Bluegrass Community Research /ID# 254653Recruiting
  • The Arthritis & Diabetes Clinic, Inc. /ID# 254014Recruiting
  • Rheumatology Associates PA - Portland /ID# 255014Recruiting
  • AA Medical Research Center - Grand Blanc /ID# 254007Recruiting
  • Advanced Rheumatology, PC /ID# 256059Recruiting
  • St. Paul Rheumatology, PA /ID# 255037Recruiting
  • Arthritis Associates /ID# 253992Recruiting
  • Kansas City Physician Partners /ID# 255035Recruiting
  • Clinvest Research LLC /ID# 254054Recruiting
  • Logan Health Research /ID# 253738Recruiting
  • Physician Research Collaboration, LLC /ID# 254012Recruiting
  • Arthritis and Osteo Assoc /ID# 252684Recruiting
  • Paramount Medical Research Con /ID# 254048Recruiting
  • Rheumatology Associates of Oklahoma /ID# 253994Recruiting
  • Clinical Research of Philadelphia, LLC /ID# 255025Recruiting
  • West Tennessee Research Institute /ID# 254620Recruiting
  • Arthritis and Rheumatology Research Institute, PLLC /ID# 254045Recruiting
  • Tekton Research, Inc. /ID# 254004Recruiting
  • Trinity Universal Research Associates - Carrollton /ID# 254648Recruiting
  • Biopharma Informatic, LLC /ID# 254053Recruiting
  • Accurate Clinical Research /ID# 254647Recruiting
  • R & H Clinical Research - 777 Katy /ID# 255024Recruiting
  • West Texas Clinical Research /ID# 253736Recruiting
  • Trinity Universal Research Associates, Inc /ID# 253995Recruiting
  • Sun Research Institute /ID# 255019Recruiting
  • Advanced Rheumatology of Houston /ID# 254003Recruiting
  • DM Clinical Research - Tomball /ID# 254001Recruiting
  • Rheumatology Clinic of Houston /ID# 254002Recruiting
  • Rheumatic Disease Center, LLP /ID# 254015Recruiting
  • Groupe de Recherche en Maladies Osseuses Inc /ID# 253409Recruiting
  • Dr Naik-Medical Professional Corporation-Alliance Health /ID# 254018Recruiting
  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836Recruiting
  • Daido Clinic /ID# 253058Recruiting
  • Sugimoto rheumatology and internal medicine clinic /ID# 252774Recruiting
  • Hamanomachi Hospital /ID# 253168Recruiting
  • Shono Rheumatism Clinic /ID# 252591Recruiting
  • Katayama Orthopedic Rheumatology Clinic /ID# 252746Recruiting
  • Sagawa Akira Rheumatology Clin /ID# 252773Recruiting
  • Matsubara Mayflower Hospital /ID# 252834Recruiting
  • Sanuki Municipal Hospital /ID# 252747Recruiting
  • Bay Side Misato Medical Center /ID# 252661Recruiting
  • Kumamoto Orthopaedic Hospital /ID# 253167Recruiting
  • Medical Corporation Keiai Kai Clinic /ID# 252750Recruiting
  • Sasebo Chuo Hospital /ID# 252662Recruiting
  • St.Luke's International Hospital /ID# 253131Recruiting
  • Keio University Hospital /ID# 253205Recruiting
  • Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057Recruiting
  • SoonChunHyang University CheonAn Hospital /ID# 254942Recruiting
  • Chonnam National University Bitgoeul Hospital /Id# 254802Recruiting
  • Chungnam National University Hospital /ID# 252159Recruiting
  • Seoul National University Hospital /ID# 252160Recruiting
  • GCM Medical Group PSC /ID# 252700Recruiting
  • Mindful Medical Research /ID# 252693Recruiting
  • The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301Recruiting
  • Queen Mary University of London /ID# 252671Recruiting
  • Portsmouth Hospitals University NHS Trust /ID# 252772Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Upadacitinib+ Adalimumab matching Placebo

Adalimumab + Upadacitinib matching Placebo

Arm Description

Participants will receive upadacitinib once a day along with matching placebo for adalimumab at eow (every other week) in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.

Participants will receive adalimumab at eow (every other week) along with matching placebo for upadacitinib once a day in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.

Secondary Outcome Measures

Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 50% improvement in tender joint count (TJC68); 50% improvement in swollen joint count (SJC66); and 50% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity measured on a Numerical Rating Scale of 0 to 10 (NRS) Patient's Global Assessment of Disease Activity (NRS) Patient's Assessment of Pain (NRS) Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.
Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Change from Baseline in Participants Assessment of Pain
Participants indicated their level of pain over the last 7 days using the Patient's Global Assessment Pain NRS. The range is 0 to 10 with no activity being indicated by 0 and severe activity by 10.
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.

Full Information

First Posted
April 4, 2023
Last Updated
October 23, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT05814627
Brief Title
Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis
Acronym
SELECT- SWITCH
Official Title
A Phase 3b/4 Randomized, Double-Blind, Double Dummy, Active Comparator-Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis on a Stable Background of MTX and Who Had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
September 23, 2025 (Anticipated)
Study Completion Date
August 12, 2026 (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
No

5. Study Description

Brief Summary
Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. 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
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA, Upadacitinib, Adalimumab, Methotrexate, MTX, TNF Inhibitor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Upadacitinib+ Adalimumab matching Placebo
Arm Type
Experimental
Arm Description
Participants will receive upadacitinib once a day along with matching placebo for adalimumab at eow (every other week) in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.
Arm Title
Adalimumab + Upadacitinib matching Placebo
Arm Type
Experimental
Arm Description
Participants will receive adalimumab at eow (every other week) along with matching placebo for upadacitinib once a day in Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
RINVOQ
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Upadacitinib Matching Placebo
Intervention Description
Oral Tablets
Intervention Type
Drug
Intervention Name(s)
Adalimumab Matching Placebo
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) <= 3.2
Description
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Low Disease Activity (LDA) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than or equal to 3.2.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
Description
Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: 50% improvement in tender joint count (TJC68); 50% improvement in swollen joint count (SJC66); and 50% improvement in at least 3 of the 5 following parameters: Physician's Global Assessment of Disease Activity measured on a Numerical Rating Scale of 0 to 10 (NRS) Patient's Global Assessment of Disease Activity (NRS) Patient's Assessment of Pain (NRS) Health Assessment Questionnaire - Disability Index (HAQ-DI) High-sensitivity C-reactive protein (hsCRP).
Time Frame
Week 12
Title
Percentage of Participants Achieving Disease Activity Score 28 C-reactive Protein [DAS28-CRP]) < 2.6
Description
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity. Clinical remission (CR) based on DAS28 (CRP) is defined as achieving a DAS28 (CRP) of less than 2.6.
Time Frame
Week 12
Title
Change from Baseline in Disease Activity Score 28 C-reactive Protein [DAS28-CRP])
Description
The DAS28-CRP is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and high-sensitivity C-reactive protein (hsCRP; in mg/L). Scores on the DAS28-CRP range from 0 to approximately 10, where higher scores indicate more disease activity.
Time Frame
Week 12
Title
Change from Baseline in Participants Assessment of Pain
Description
Participants indicated their level of pain over the last 7 days using the Patient's Global Assessment Pain NRS. The range is 0 to 10 with no activity being indicated by 0 and severe activity by 10.
Time Frame
Week 12
Title
Change from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Description
The HAQ-DI assesses physical function in RA. The HAQ-DI score is the average of the highest score in each of eight categories. The total score is between 0-3.0, in 0.125 increments. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Rheumatoid Arthritis (RA) for >= 3 months based on the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) classification criteria for RA. Treated for >= 3 consecutive months prior to screening with 1 tumor necrosis factor inhibitor (TNFi) (originator or biosimilar) for RA (except adalimumab [originator or biosimilar]), but continue to exhibit active RA, or had to discontinue due to intolerability, irrespective of treatment duration. Up to 15% of participants who were intolerant to 1 TNFi will be allowed to enroll. On oral or parenteral methotrexate (MTX) therapy >= 3 months and on a stable prescription of 15 to 25 mg/week (or >= 10 mg/week in participants intolerant of MTX at doses >= 15 mg/week) for >= 4 weeks prior to the first dose of study drug. In addition, all participants should take a dietary supplement of folic acid or folinic acid throughout the study participation. For participants in China, Japan, Korea, or Taiwan, a stable dose of MTX >= 7.5 mg/week is acceptable. Additional local requirements for MTX may apply. Meets both of the following disease activity criteria: >= 6 swollen joint (based on 66 joint counts) and >= 6 tender joints (based on 68 joint counts) at screening and baseline; High-sensitivity C-reactive protein (hsCRP) >= 3 mg/L (central lab, upper limit of normal [ULN] 2.87 mg/L) at screening. Exclusion Criteria: History of any arthritis with onset prior to age 17 years or current diagnosis of inflammatory joint disease other than Rheumatoid Arthritis (RA). Prior exposure to any janus kinase (JAK) inhibitor. Prior exposure to adalimumab (original or biosimilar). Prior exposure to a non-TNFi biologic disease modifying anti-rheumatic drug (bDMARD).
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# 253431
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001-6299
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 255018
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306-9802
Country
United States
Individual Site Status
Recruiting
Facility Name
Sun Valley Arthritis Center Ltd. /ID# 254654
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Individual Site Status
Recruiting
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 253432
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Individual Site Status
Recruiting
Facility Name
AZ Arthritis and Rheumotology Research, PLLC /ID# 255021
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032-9306
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates - Tucson /ID# 255017
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Rheumatism Associates /ID# 254013
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401-6251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
870-333-2721
Facility Name
Newport Huntington Medical Group /ID# 252687
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648-5994
Country
United States
Individual Site Status
Recruiting
Facility Name
Purushotham & Akther Kotha MD, Inc /ID# 252704
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(619) 229-1995 x 208
Facility Name
Valerius Medical Group & Research Center of Greater Long Beach, Inc /ID# 252692
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720-5402
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Center of San Diego /ID# 255038
City
San Diego
State/Province
California
ZIP/Postal Code
92128-2549
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Clinical Trials /ID# 252689
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-3951
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Rheumatology Center /ID# 252688
City
Woodland Hills
State/Province
California
ZIP/Postal Code
91364
Country
United States
Individual Site Status
Recruiting
Facility Name
Denver Arthritis Clinic /ID# 254058
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research /ID# 255036
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 253733
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Name
Bay Area Arthritis and Osteo /ID# 254046
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# 254649
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Debary, LLC /ID# 253735
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Individual Site Status
Recruiting
Facility Name
Neoclinical Research /ID# 254622
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
305-456-9062
Facility Name
Life Clinical Trials /ID# 256061
City
Margate
State/Province
Florida
ZIP/Postal Code
33063-5704
Country
United States
Individual Site Status
Recruiting
Facility Name
Lakes Research, LLC /ID# 255023
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
HMD Research LLC /ID# 253732
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Millennium Research /ID# 253744
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
BayCare Medical Group /ID# 253799
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of West Florida - Tampa /ID# 255264
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-1246
Country
United States
Individual Site Status
Recruiting
Facility Name
BayCare Medical Group, Inc. /ID# 255268
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# 254623
City
Marietta
State/Province
Georgia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Recruiting
Facility Name
Crowley CORE, LLC - Hinsdale Orthopaedics /ID# 254712
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521-3186
Country
United States
Individual Site Status
Recruiting
Facility Name
Greater Chicago Specialty Physicians /ID# 254000
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# 253999
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
Deerbrook Medical Associates /ID# 254008
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
Individual Site Status
Recruiting
Facility Name
Qualmedica Research - Evansville /ID# 254005
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715-2813
Country
United States
Individual Site Status
Recruiting
Facility Name
Bluegrass Community Research /ID# 254653
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Individual Site Status
Recruiting
Facility Name
The Arthritis & Diabetes Clinic, Inc. /ID# 254014
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology Associates PA - Portland /ID# 255014
City
Portland
State/Province
Maine
ZIP/Postal Code
04102-2643
Country
United States
Individual Site Status
Recruiting
Facility Name
AA Medical Research Center - Grand Blanc /ID# 254007
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
810-694-0082
Facility Name
Advanced Rheumatology, PC /ID# 256059
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Paul Rheumatology, PA /ID# 255037
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Associates /ID# 253992
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Individual Site Status
Recruiting
Facility Name
Kansas City Physician Partners /ID# 255035
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64151
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research LLC /ID# 254054
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Logan Health Research /ID# 253738
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Name
Physician Research Collaboration, LLC /ID# 254012
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Osteo Assoc /ID# 252684
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Recruiting
Facility Name
Paramount Medical Research Con /ID# 254048
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
440-826-0742
Facility Name
Rheumatology Associates of Oklahoma /ID# 253994
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116-7226
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Philadelphia, LLC /ID# 255025
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
212-676-6696
Facility Name
West Tennessee Research Institute /ID# 254620
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Rheumatology Research Institute, PLLC /ID# 254045
City
Allen
State/Province
Texas
ZIP/Postal Code
75013-6147
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
(972) 798-8553
Facility Name
Tekton Research, Inc. /ID# 254004
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
512-388-5717
Facility Name
Trinity Universal Research Associates - Carrollton /ID# 254648
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Individual Site Status
Recruiting
Facility Name
Biopharma Informatic, LLC /ID# 254053
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Individual Site Status
Recruiting
Facility Name
Accurate Clinical Research /ID# 254647
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Individual Site Status
Recruiting
Facility Name
R & H Clinical Research - 777 Katy /ID# 255024
City
Katy
State/Province
Texas
ZIP/Postal Code
77450-2244
Country
United States
Individual Site Status
Recruiting
Facility Name
West Texas Clinical Research /ID# 253736
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
8069931040
Facility Name
Trinity Universal Research Associates, Inc /ID# 253995
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Individual Site Status
Recruiting
Facility Name
Sun Research Institute /ID# 255019
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Rheumatology of Houston /ID# 254003
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
281-766-7886
Facility Name
DM Clinical Research - Tomball /ID# 254001
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
2815170550
Facility Name
Rheumatology Clinic of Houston /ID# 254002
City
Tomball
State/Province
Texas
ZIP/Postal Code
77377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
2815170550
Facility Name
Rheumatic Disease Center, LLP /ID# 254015
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Individual Site Status
Recruiting
Facility Name
Groupe de Recherche en Maladies Osseuses Inc /ID# 253409
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 254018
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7H 5M7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 252836
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Individual Site Status
Recruiting
Facility Name
Daido Clinic /ID# 253058
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sugimoto rheumatology and internal medicine clinic /ID# 252774
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0068
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hamanomachi Hospital /ID# 253168
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shono Rheumatism Clinic /ID# 252591
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0002
Country
Japan
Individual Site Status
Recruiting
Facility Name
Katayama Orthopedic Rheumatology Clinic /ID# 252746
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sagawa Akira Rheumatology Clin /ID# 252773
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Matsubara Mayflower Hospital /ID# 252834
City
Kato-shi
State/Province
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sanuki Municipal Hospital /ID# 252747
City
Sanuki-shi
State/Province
Kagawa
ZIP/Postal Code
769-2393
Country
Japan
Individual Site Status
Recruiting
Facility Name
Bay Side Misato Medical Center /ID# 252661
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
781-0112
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kumamoto Orthopaedic Hospital /ID# 253167
City
Kumamoto shi
State/Province
Kumamoto
ZIP/Postal Code
8620975
Country
Japan
Individual Site Status
Recruiting
Facility Name
Medical Corporation Keiai Kai Clinic /ID# 252750
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
880-0053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Sasebo Chuo Hospital /ID# 252662
City
Sasebo-shi
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Individual Site Status
Recruiting
Facility Name
St.Luke's International Hospital /ID# 253131
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Keio University Hospital /ID# 253205
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 253057
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
752-0976
Country
Japan
Individual Site Status
Recruiting
Facility Name
SoonChunHyang University CheonAn Hospital /ID# 254942
City
Cheonan-si
State/Province
Chungcheongnamdo
ZIP/Postal Code
31151
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chonnam National University Bitgoeul Hospital /Id# 254802
City
Gwangju-Gwangyeoksi
State/Province
Gwangju Gwang Yeogsi
ZIP/Postal Code
61748
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chungnam National University Hospital /ID# 252159
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 252160
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
GCM Medical Group PSC /ID# 252700
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Mindful Medical Research /ID# 252693
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
The Queen Elizabeth Hospital, Kings Lynn NHS Foundation Trust /ID# 252301
City
Kings Lynn
State/Province
Norfolk
ZIP/Postal Code
PE30 4ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Queen Mary University of London /ID# 252671
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Portsmouth Hospitals University NHS Trust /ID# 252772
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
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=M23-700
Description
Related Info

Learn more about this trial

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

We'll reach out to this number within 24 hrs