A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

Rheumatoid Arthritis (RA) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03823391
• Other study ID #: M16-560
• Secondary ID: 2018-003053-21
• Status: Completed
• Phase: Phase 2
• Start date: March 27, 2019
• Est. completion date: August 26, 2020

Study information

• Verified date: June 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 26, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	Charite Research Organisation GmbH /ID# 210216	Berlin
Hungary	DRC Gyogyszervizsgalo Kozpont Kft. /ID# 210159	Balatonfüred	Veszprem
Hungary	Budai Irgalmasrendi Korhaz /ID# 208877	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont /ID# 210164	Debrecen
Hungary	CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 210055	Miskolc	Borsod-Abauj-Zemplen
Israel	Rambam Health Care Campus /ID# 212747	Haifa
Israel	Sheba Medical Center /ID# 211339	Ramat Gan
Netherlands	Academisch Medical center Amsterdam /ID# 209303	Amsterdam	Noord-Holland
Poland	SANUS Szpital Specjalistyczny /ID# 209022	Stalowa Wola
Poland	Reumatika - Centrum Reumatologii NZOZ /ID# 209220	Warsaw
Puerto Rico	GCM Medical Group, PSC /ID# 208154	San Juan
Puerto Rico	Mindful Medical Research /ID# 208403	San Juan
United States	PCCR Solution /ID# 215457	Colleyville	Texas
United States	Duke Early Phase Research Unit (DCRI) /ID# 213212	Durham	North Carolina
United States	C.V. Mehta MD, Med Corporation /ID# 213068	Hemet	California
United States	Rheum Assoc of North Alabama /ID# 213626	Huntsville	Alabama
United States	Institute of Arthritis Researc /ID# 213043	Idaho Falls	Idaho
United States	West Tennessee Research Inst /ID# 208838	Jackson	Tennessee
United States	Paramount Medical Research Con /ID# 209042	Middleburg Heights	Ohio
United States	Suncoast Clinical Research /ID# 213973	New Port Richey	Florida
United States	Arthritis Center, Inc. /ID# 213972	Palm Harbor	Florida
United States	AZ Arthritis and Rheum Researc /ID# 208515	Phoenix	Arizona
United States	Trinity Universal Research Association /ID# 209167	Plano	Texas
United States	Clinvest Research LLC /ID# 215451	Springfield	Missouri
United States	W. Broward Rheum Assoc Inc. /ID# 211017	Tamarac	Florida
United States	BayCare Medical Group, Inc. /ID# 213935	Tampa	Florida
United States	Robin K. Dore MD, Inc /ID# 213045	Tustin	California
United States	Inland Rheum & Osteo Med Grp /ID# 213044	Upland	California
United States	STAT Research, Inc. /ID# 213933	Vandalia	Ohio
United States	PRN Professional Research Network of Kansas, LLC /ID# 213046	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  Israel,  Netherlands,  Poland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline to Week 12 in Clinical Disease Activity Index (CDAI)	The clinical disease activity index (CDAI) is a composite index for assessing disease activity based on the summation of the counts of tender joint count (out of 28 evaluated joints) and swollen joint count (out of 28 evaluated joints), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0 to 10 cm. The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.	Baseline and Week 12
Secondary	Change From Baseline in Simplified Disease Activity Index (SDAI)	The SDAI is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), Patient Global Assessment of Disease Activity and Physician Global Assessment of Disease Activity both measured on a VAS from 0-10 cm and level of CRP (in mg/dL; normal < 1 mg/dL). The SDAI has a range from 0 to 86, with higher scores indicating higher disease activity. A negative change from Baseline indicates improvement in disease activity.	Baseline and Week 12
Secondary	Change From Baseline to Week 12 in DAS28 (Erythrocyte Sedimentation Rate [ESR])	The DAS28 (ESR) 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 VAS from 0-100 mm), and ESR (in mm/hr). Scores on the DAS28 (ESR) range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline indicates improvement in disease activity.	Baseline and Week 12
Secondary	Percentage of Participants Achieving Low Disease Activity (LDA) Based on DAS28 (CRP) at Week 12	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 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 DAS28 (CRP) score less than or equal to 3.2 indicates low disease activity.	Week 12
Secondary	Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12	Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria: = 50% improvement in 68-tender joint count; = 50% improvement in 66-swollen joint count; and; = 50% improvement in at least 3 of the 5 following parameters: Physician global assessment of disease activity; Patient global assessment of disease activity; Patient assessment of pain; Health Assessment Questionnaire - Disability Index (HAQ-DI); High-sensitivity C-reactive protein (hsCRP).	Baseline and Week 12

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