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

NCT03823391 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-07-19

Study results available
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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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

ABBV-3373

ABBV-3373 is administered as intravenous (IV) infusion

DRUG

Placebo for ABBV-3373

Placebo for ABBV-3373 is administered as IV infusion

DRUG

Adalimumab

Adalimumab is administered as subcutaneous (SC) injection

DRUG

Placebo for adalimumab

Placebo for adalimumab is administered as subcutaneous (SC) injection

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2020-04-08
Completion
2020-08-26
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823391 on ClinicalTrials.gov