MSB11022 in moderately to severely active rheumatoid arthritis
- Conditions
- moderately to severely active rheumatoid arthritisMedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2016-002852-26-CZ
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 288
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;<br> Secondary Objective: To compare the efficacy, immunogenicity and QoL data of MSB11022 to<br> reference product in patients with moderately to severely active RA.<br> ;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 Outcome Measures
Name Time Method <br> Secondary end point(s): Key secondary endpoint:<br> American College of Rheumatology 20% response criteria (ACR20)<br> ;Timepoint(s) of evaluation of this end point: at week 12