NCT03823391

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-27
• Primary completion: 2020-04-08
• Completion: 2020-08-26
• First posted: 2019-01-30
• Last updated: 2021-07-19
• Results posted: 2021-07-19

Locations

30 sites across 7 countries: United States, Germany, Hungary, Israel, Netherlands, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study