MSB11022 in moderately to severely active rheumatoid arthritis

Phase 1

• Conditions: moderately to severely active rheumatoid arthritis; MedDRA version: 19.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2016-002852-26-HU
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-29
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified