MSB11022 in moderately to severely active rheumatoid arthritis

A multicenter, randomized, double-blind, Phase III trial to evaluate the safety, immunogenicity, and efficacy of MSB11022 compared with Humira® in patients with moderately to severely active rheumatoid arthritis - AURIEL-RA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002852-26-CZ

Enrollment

260

Registered

2016-09-21

Start date

2016-12-07

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moderately to severely active rheumatoid arthritis MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: adalimumab Product Code: MSB11022 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria -At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline -Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: -Evidence of untreated or inadequately treated latent or active TB -Evidence of uncontrolled, clinically significant diseases -Any second DMARD must be washed out prior to the first study dose

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the safety profile of MSB11022 compared to reference product in patients with moderately to severely active rheumatoid arthritis (RA) up to Week 52.; Secondary Objective: To compare the efficacy, immunogenicity and QoL data of MSB11022 to reference product in patients with moderately to severely active RA. ;Primary end point(s): Incidence of adverse events including and up to Week 52.;Timepoint(s) of evaluation of this end point: at and up to week 52	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the safety profile of MSB11022 compared to reference product in patients with moderately to severely active rheumatoid arthritis (RA) up to Week 52.; Secondary Objective: To compare the efficacy, immunogenicity and QoL data of MSB11022 to reference product in patients with moderately to severely active RA. ;Primary end point(s): Incidence of adverse events including and up to Week 52.;Timepoint(s) of evaluation of this end point: at and up to week 52

—

Secondary

Measure	Time frame
Secondary end point(s): Key secondary endpoint: American College of Rheumatology 20% response criteria (ACR20) ;Timepoint(s) of evaluation of this end point: at week 12	—

Countries

Bulgaria, Czech Republic, Germany, Hungary, Lithuania, Poland, United Kingdom

Contacts

Public ContactCommunication Center Merck KGaA

Merck KGaA

service@merckgroup.com496151725200

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026