A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
NCT ID: NCT03823391
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2019-03-27
2020-08-26
Brief Summary
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Detailed Description
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In the active-controlled period of the first 12 weeks of treatment, participants are randomized to receive either ABBV-3373 100 mg intravenously (IV) every other week (EOW) or adalimumab 80 mg subcutaneously (SC) EOW according to a 2:1 ratio.
At Week 12, the administration of ABBV-3373 was to stop to assess the durability of the observed clinical effects up to 24 weeks. Participants randomized to ABBV-3373 were to receive placebo injections, whereas participants randomized into the adalimumab arm were to continue their 80 mg dosing.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABBV-3373 Followed by Placebo
Participants 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.
ABBV-3373
ABBV-3373 is administered as intravenous (IV) infusion
Placebo for adalimumab
Placebo for adalimumab is administered as subcutaneous (SC) injection
Adalimumab
Participants 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.
Placebo for ABBV-3373
Placebo for ABBV-3373 is administered as IV infusion
Adalimumab
Adalimumab is administered as subcutaneous (SC) injection
Interventions
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ABBV-3373
ABBV-3373 is administered as intravenous (IV) infusion
Placebo for ABBV-3373
Placebo for ABBV-3373 is administered as IV infusion
Adalimumab
Adalimumab is administered as subcutaneous (SC) injection
Placebo for adalimumab
Placebo for adalimumab is administered as subcutaneous (SC) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Rheum Assoc of North Alabama /ID# 213626
Huntsville, Alabama, United States
AZ Arthritis and Rheum Researc /ID# 208515
Phoenix, Arizona, United States
C.V. Mehta MD, Med Corporation /ID# 213068
Hemet, California, United States
Robin K. Dore MD, Inc /ID# 213045
Tustin, California, United States
Inland Rheum & Osteo Med Grp /ID# 213044
Upland, California, United States
Suncoast Clinical Research /ID# 213973
New Port Richey, Florida, United States
Arthritis Center, Inc. /ID# 213972
Palm Harbor, Florida, United States
W. Broward Rheum Assoc Inc. /ID# 211017
Tamarac, Florida, United States
BayCare Medical Group, Inc. /ID# 213935
Tampa, Florida, United States
Institute of Arthritis Researc /ID# 213043
Idaho Falls, Idaho, United States
PRN Professional Research Network of Kansas, LLC /ID# 213046
Wichita, Kansas, United States
Clinvest Research LLC /ID# 215451
Springfield, Missouri, United States
Duke Early Phase Research Unit (DCRI) /ID# 213212
Durham, North Carolina, United States
Paramount Medical Research Con /ID# 209042
Middleburg Heights, Ohio, United States
STAT Research, Inc. /ID# 213933
Vandalia, Ohio, United States
West Tennessee Research Inst /ID# 208838
Jackson, Tennessee, United States
PCCR Solution /ID# 215457
Colleyville, Texas, United States
Trinity Universal Research Association /ID# 209167
Plano, Texas, United States
Charite Research Organisation GmbH /ID# 210216
Berlin, , Germany
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055
Miskolc, Borsod-Abauj Zemplen county, Hungary
DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159
Balatonfüred, Veszprém megye, Hungary
Budai Irgalmasrendi Korhaz /ID# 208877
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont /ID# 210164
Debrecen, , Hungary
Rambam Health Care Campus /ID# 212747
Haifa, , Israel
Sheba Medical Center /ID# 211339
Ramat Gan, , Israel
Academisch Medical center Amsterdam /ID# 209303
Amsterdam, North Holland, Netherlands
SANUS Szpital Specjalistyczny /ID# 209022
Stalowa Wola, , Poland
Reumatika - Centrum Reumatologii NZOZ /ID# 209220
Warsaw, , Poland
GCM Medical Group, PSC /ID# 208154
San Juan, , Puerto Rico
Mindful Medical Research /ID# 208403
San Juan, , Puerto Rico
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2018-003053-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-560
Identifier Type: -
Identifier Source: org_study_id
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