A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABBV-3373 and ABBV-154 in Participants With Moderate to Severe Rheumatoid Arthritis

Study Purpose

This is a adalimumab active-controlled study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, immunogenicity and efficacy following multiple intravenous (IV) injections of ABBV-3373, multiple IV injections of ABBV-154, or multiple subcutaneous (SC) injections of adalimumab in participants with Rheumatoid Arthritis (RA) on background methotrexate (MTX). This study will also compare adalimumab with a synthetic control arm using historical placebo participants from similar trials to establish assay sensitivity.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

- ABBV-3373 Cohort: Participant has an incomplete response to MTX.

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.

- ABBV-154 Cohort: Participant has an incomplete response response to prior biologic disease-modifying antirheumatic drug (bDMARD)and/or targeted synthetic disease-modifying antirheumatic drug (tsDMARD) therapy (Bio-IR).

Participant must be expected to be able to continue on stable dose of MTX for the duration of study participation.

Exclusion Criteria:

- For ABBV-3373 Cohort: Participants previously exposed to adalimumab or other anti-tumor necrosis factor (TNF) biologics.

- For ABBV-3373 Cohort: 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03823391
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	AbbVie
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	AbbVie Inc.
Principal Investigator Affiliation	AbbVie
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany, Hungary, Israel, Netherlands, Poland, Puerto Rico, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis (RA)
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: ABBV-3373 Cohort: ABBV-3373

Participants will be administered with ABBV-3373 dose A and placebo for adalimumab every other week for 12 weeks. After 12 weeks, participants will receive placebo for adalimumab every other week until Week 22.

Experimental: ABBV-3373 Cohort: Adalimumab

Participants will be administered with placebo for ABBV-3373 and adalimumab dose A every other week for 12 weeks. After 12 weeks, participants will receive adalimumab dose A every other week until Week 22.

Experimental: ABBV-154 Cohort: ABBV-154 (Dose A)

Participants will be administered with ABBV-154 dose A and placebo for adalimumab every other week for 12 weeks. After 12 weeks, participants will receive placebo for adalimumab every other week until Week 22.

Experimental: ABBV-154 Cohort: ABBV-154 (Dose B)

Participants will be administered with ABBV-154 dose B and placebo for adalimumab every other week for 12 weeks. After 12 weeks, participants will receive placebo for adalimumab every other week until Week 22.

Experimental: ABBV-154 Cohort: ABBV-154 (Dose C)

Participants will be administered with ABBV-154 dose C and placebo for adalimumab every other week for 12 weeks. After 12 weeks, participants will receive placebo for adalimumab every other week until Week 22.

Experimental: ABBV-154 Cohort: Adalimumab

Participants will be administered with placebo for ABBV-154 and adalimumab dose A every other week for 12 weeks. After 12 weeks, participants will receive adalimumab dose A every other week until Week 22.

Interventions

Drug: - ABBV-3373

ABBV-3373 is administered as intravenous (IV) injection

Drug: - Placebo for ABBV-3373

Placebo for ABBV-3373 is administered as intravenous (IV) injection

Drug: - Adalimumab

Adalimumab is administered as subcutaneous (SC) injection

Drug: - Placebo for adalimumab

Placebo for adalimumab is administered as subcutaneous (SC) injection

Drug: - ABBV-154

ABBV-154 is administered as intravenous (IV) injection

Drug: - Placebo for ABBV-154

Placebo for ABBV-154 is administered as intravenous (IV) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Rheum Assoc of North Alabama /ID# 213626, Huntsville, Alabama

Status

Completed

Address

Rheum Assoc of North Alabama /ID# 213626

Huntsville, Alabama, 35801

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