MSB11022 in moderately to severely active rheumatoid arthritis

Phase 1

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

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-23
• Study Completion: 2018-08-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 288

Inclusion Criteria

Male or female patients = 18 years old with a clinical diagnosis of moderately to severely active rheumatoid arthritis (RA) with disease duration of at least 6 months from confirmed diagnosis (defined by the 2010 revised ACR/EULAR 2010 criteria or the 1987 Criteria of American Rheumatology Association) despite methotrexate (MTX) therapy (defined as = 6 swollen joints and = 6 tender joints (from the 66/68 joint count system) at screening and randomization and either erythrocyte sedimentation rate = 28 mm/h or serum C reactive protein (CRP) = 1.0 mg/dL at screening.

Patient must have been treated with MTX for a total of at least 12 weeks prior to baseline and must have been on both a stable route of administration (oral or parenteral) and stable dose of MTX (10 to 25 mg/week) for at least 4 weeks prior to screening.

Patients must have discontinued infliximab (either originator or investigational or approved biosimilar), certolizumab pegol (either originator or investigational or approved biosimilar) or golimumab (either originator or investigational or approved biosimilar) 8 weeks prior to screening, or etanercept (either originator or investigational or approved biosimilar) 4 weeks prior screening.

Other protocol-defined criteria could apply
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

A patient will be excluded if he or she is considered ACR functional class IV as defined by the ACR classification of functional status or wheelchair/bedbound or has diagnoses of Felty’s syndrome or any other inflammatory arthritides/systemic autoimmune disease other than secondary Sjögren’s syndrome.

Patient must not have received therapy with leflunomide within 12 weeks prior to baseline (Day 1); disease-modifying antirheumatic drugs other than MTX including but not limited to oral or injectable gold, sulfasalazine, azathioprine, penicillamine, cyclosporine, or tacrolimus within 4 weeks prior to baseline; or increasing doses of non steroidal anti inflammatory drugs (including low dose aspirin and COX-2 inhibitors) in the 2 weeks prior to baseline; had prior exposure to alkylating agents, such as chlorambucil or cyclophosphamide; use oral glucocorticoids > 10 mg/day prednisone or equivalent (dose must have been stable for the 4 weeks prior to baseline); or received any intra-articular, intravenous, or intramuscular use of corticosteroids in the 6 weeks prior to baseline.

Patients will also be excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (including active or latent tuberculosis [TB]); history of active or latent TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex.

Patients will be excluded if they have a concomitant diagnosis or history of congestive heart failure (New York Heart Association [NYHA] class III or IV).

Other protocol-defined criteria could apply

Study & Design

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