MSB11022 in moderately to severely active rheumatoid arthritis

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2016-002852-26-CZ
• Date of registration: 21/09/2016
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA
• Public title: MSB11022 in moderately to severely active rheumatoid arthritis
• Scientific title: 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
• Date of first enrolment: 07/12/2016
• Target sample size: 260
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-002852-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Communication Center Merck KGaA
• Affiliation: Merck KGaA

• Name: Communication Center Merck KGaA
• Affiliation: Merck KGaA

Key inclusion & exclusion 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:
-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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

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

Intervention(s)

Product Name: adalimumab
Product Code: MSB11022
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Current Sponsor code: MSB11022
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Humira
Product Name: Humira
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

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.

Primary end point(s): Incidence of adverse events including and 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.

Timepoint(s) of evaluation of this end point: at and up to week 52

Secondary Outcome(s)

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

Secondary ID(s)

MS200588-0004

Source(s) of Monetary Support

Merck KGaA

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 13/07/2019
• Date Completed: 27/08/2018
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-002852-26/results