Clinical trial NCT03823391: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid Arthritis (RA)
ABBV-3373
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study consists of a 12-week double-blind active-controlled phase and a 12 week double-blind extension period.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline to Week 12 in Disease Activity Score (DAS) 28 (C-reactive Protein [CRP])
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)
timeFrame: Baseline and Week 12
measure: Change From Baseline in Simplified Disease Activity Index (SDAI)
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])
timeFrame: Baseline and Week 12
measure: Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12
timeFrame: Week 12
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheum Assoc of North Alabama /ID# 213626
state: Alabama
city: Phoenix
country: United States
facility: AZ Arthritis and Rheum Researc /ID# 208515
state: Arizona
city: Hemet
country: United States
facility: C.V. Mehta MD, Med Corporation /ID# 213068
state: California
city: Tustin
country: United States
facility: Robin K. Dore MD, Inc /ID# 213045
state: California
city: Upland
country: United States
facility: Inland Rheum & Osteo Med Grp /ID# 213044
state: California
city: New Port Richey
country: United States
facility: Suncoast Clinical Research /ID# 213973
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc. /ID# 213972
state: Florida
city: Tamarac
country: United States
facility: W. Broward Rheum Assoc Inc. /ID# 211017
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group, Inc. /ID# 213935
state: Florida
city: Idaho Falls
country: United States
facility: Institute of Arthritis Researc /ID# 213043
state: Idaho
city: Wichita
country: United States
facility: PRN Professional Research Network of Kansas, LLC /ID# 213046
state: Kansas
city: Springfield
country: United States
facility: Clinvest Research LLC /ID# 215451
state: Missouri
city: Durham
country: United States
facility: Duke Early Phase Research Unit (DCRI) /ID# 213212
state: North Carolina
city: Middleburg Heights
country: United States
facility: Paramount Medical Research Con /ID# 209042
state: Ohio
city: Vandalia
country: United States
facility: STAT Research, Inc. /ID# 213933
state: Ohio
city: Jackson
country: United States
facility: West Tennessee Research Inst /ID# 208838
state: Tennessee
city: Colleyville
country: United States
facility: PCCR Solution /ID# 215457
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Association /ID# 209167
state: Texas
city: Berlin
country: Germany
facility: Charite Research Organisation GmbH /ID# 210216
city: Miskolc
country: Hungary
facility: CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055
state: Borsod-Abauj-Zemplen
city: Balatonfüred
country: Hungary
facility: DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159
state: Veszprem
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz /ID# 208877
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont /ID# 210164
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 212747
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 211339
city: Amsterdam
country: Netherlands
facility: Academisch Medical center Amsterdam /ID# 209303
state: Noord-Holland
city: Stalowa Wola
country: Poland
facility: SANUS Szpital Specjalistyczny /ID# 209022
city: Warsaw
country: Poland
facility: Reumatika - Centrum Reumatologii NZOZ /ID# 209220
city: San Juan
country: Puerto Rico
facility: GCM Medical Group, PSC /ID# 208154
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 208403
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: