A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
A Randomized, Double-Blind, Double-Dummy, Active Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Subjects With Moderate to Severe Rheumatoid Arthritis
2 other identifiers
interventional
48
7 countries
30
Brief Summary
This study will assess the safety, tolerability, and efficacy of ABBV-3373 in participants with moderately to severely active rheumatoid arthritis (RA) on background methotrexate (MTX) compared with adalimumab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2019
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2019
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedStudy Start
First participant enrolled
March 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 26, 2020
CompletedResults Posted
Study results publicly available
July 19, 2021
CompletedJuly 19, 2021
June 1, 2021
1 year
January 29, 2019
June 29, 2021
June 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [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 (measured on a visual analog scale \[VAS\] from 0-100 mm), and hsCRP (in mg/L). Scores on the DAS28 (CRP) range from 0.96 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.
Baseline and Week 12
Secondary Outcomes (5)
Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
Baseline and Week 12
Change From Baseline in Simplified Disease Activity Index (SDAI)
Baseline and Week 12
Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
Baseline and Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
Week 12
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
Baseline and Week 12
Study Arms (2)
ABBV-3373 Followed by Placebo
EXPERIMENTALParticipants will be administered with 100 mg ABBV-3373 by intravenous infusion and placebo to adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive placebo to adalimumab every other week until Week 22.
Adalimumab
EXPERIMENTALParticipants will be administered with placebo to ABBV-3373 by intravenous infusion and 80 mg adalimumab by subcutaneous injection every other week for 12 weeks. After 12 weeks, participants will receive 80 mg adalimumab subcutaneously every other week until Week 22.
Interventions
Adalimumab is administered as subcutaneous (SC) injection
Placebo for adalimumab is administered as subcutaneous (SC) injection
Eligibility Criteria
You may qualify if:
- Participant has the clinical diagnosis of RA for \> 3 months based on the 1987 American College of Rheumatology (ACR) classification criteria or 2010 ACR/European League against Rheumatism (EULAR) criteria.
- Participant meets the following disease activity criteria: \>= 4 swollen joints (based on 28 joint count) and \>= 4 tender joints (based on 28 joint count) at Screening and Baseline visits and disease activity score (28 joints) (DAS28) C-reactive protein (CRP) \>= 3.2 at Screening.
- Participant has an incomplete response to methotrexate. Participants must have been on oral or parental 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. Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.
You may not qualify if:
- Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.
- Participants previously exposed to non-anti-TNF biologics or targeted synthetic disease-modifying antirheumatic drugs (DMARDs) for RA, with exception of participants exposed for less than 3 months and terminated not due to lack of efficacy or intolerability.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (30)
Rheum Assoc of North Alabama /ID# 213626
Huntsville, Alabama, 35801, United States
AZ Arthritis and Rheum Researc /ID# 208515
Phoenix, Arizona, 85032, United States
C.V. Mehta MD, Med Corporation /ID# 213068
Hemet, California, 92543, United States
Robin K. Dore MD, Inc /ID# 213045
Tustin, California, 92780, United States
Inland Rheum & Osteo Med Grp /ID# 213044
Upland, California, 91786, United States
Suncoast Clinical Research /ID# 213973
New Port Richey, Florida, 34652, United States
Arthritis Center, Inc. /ID# 213972
Palm Harbor, Florida, 34684, United States
W. Broward Rheum Assoc Inc. /ID# 211017
Tamarac, Florida, 33321, United States
BayCare Medical Group, Inc. /ID# 213935
Tampa, Florida, 33614-7101, United States
Institute of Arthritis Researc /ID# 213043
Idaho Falls, Idaho, 83404, United States
PRN Professional Research Network of Kansas, LLC /ID# 213046
Wichita, Kansas, 67205, United States
Clinvest Research LLC /ID# 215451
Springfield, Missouri, 65810-2607, United States
Duke Early Phase Research Unit (DCRI) /ID# 213212
Durham, North Carolina, 27710, United States
Paramount Medical Research Con /ID# 209042
Middleburg Heights, Ohio, 44130, United States
STAT Research, Inc. /ID# 213933
Vandalia, Ohio, 45377-9464, United States
West Tennessee Research Inst /ID# 208838
Jackson, Tennessee, 38305, United States
PCCR Solution /ID# 215457
Colleyville, Texas, 76034, United States
Trinity Universal Research Association /ID# 209167
Plano, Texas, 75024-5283, United States
Charite Research Organisation GmbH /ID# 210216
Berlin, 10117, Germany
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055
Miskolc, Borsod-Abauj Zemplen county, 3529, Hungary
DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159
Balatonfüred, Veszprém megye, 8230, Hungary
Budai Irgalmasrendi Korhaz /ID# 208877
Budapest, 1023, Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 210164
Debrecen, 4032, Hungary
Rambam Health Care Campus /ID# 212747
Haifa, 3109601, Israel
Sheba Medical Center /ID# 211339
Ramat Gan, 5239424, Israel
Academisch Medical center Amsterdam /ID# 209303
Amsterdam, North Holland, 1105 AZ, Netherlands
SANUS Szpital Specjalistyczny /ID# 209022
Stalowa Wola, 37-450, Poland
Reumatika - Centrum Reumatologii NZOZ /ID# 209220
Warsaw, 02-691, Poland
GCM Medical Group, PSC /ID# 208154
San Juan, 00909, Puerto Rico
Mindful Medical Research /ID# 208403
San Juan, 00918-3756, Puerto Rico
Related Publications (1)
Buttgereit F, Aelion J, Rojkovich B, Zubrzycka-Sienkiewicz A, Chen S, Yang Y, Arikan D, D'Cunha R, Pang Y, Kupper H, Radstake T, Amital H. Efficacy and Safety of ABBV-3373, a Novel Anti-Tumor Necrosis Factor Glucocorticoid Receptor Modulator Antibody-Drug Conjugate, in Adults with Moderate-to-Severe Rheumatoid Arthritis Despite Methotrexate Therapy: A Randomized, Double-Blind, Active-Controlled Proof-of-Concept Phase IIa Trial. Arthritis Rheumatol. 2023 Jun;75(6):879-889. doi: 10.1002/art.42415. Epub 2023 Apr 2.
PMID: 36512671DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2019
First Posted
January 30, 2019
Study Start
March 27, 2019
Primary Completion
April 8, 2020
Study Completion
August 26, 2020
Last Updated
July 19, 2021
Results First Posted
July 19, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.