EUCTR2019-004369-42-SK
Active, not recruiting
Phase 1
A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I
ConditionsModerately to severely active Rheumatoid ArthritisMedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
DrugsRoActemra(R)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Moderately to severely active Rheumatoid Arthritis
- Sponsor
- Fresenius Kabi SwissBioSim GmbH
- Enrollment
- 542
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Are \=18 years of age.
- •2\. Diagnosis of rheumatoid arthritis according to the revised 1987
- •ACR/EULAR Classification 2010 criteria with disease duration of \=6
- •3\. Have moderately to severely active rheumatoid arthritis as defined by:
- •a.Swollen Joint Count \=6 (66 joint count) and Tender Joint Count \=6 (68
- •joint count)
- •4\. Must have been treated with methotrexate for at least 12 consecutive
- •weeks immediately prior to randomization and are on a stable dose
- •between 10 and 25 mg/week methotrexate for the last 8 weeks prior to
- •5\. Have had previous inadequate clinical response to at least one
Exclusion Criteria
- •1\. American College of Rheumatology functional class IV as defined by the ACR classification of functional status or heelchair/bedbound.
- •2\. Rheumatic autoimmune disease or history of/current inflammatory joint disease other than rheumatoid arthritis or significant systemic involvement secondary to rheumatoid arthritis. Sjögren's syndrome secondary to rheumatoid arthritis is allowed.
- •3\. Previously received tocilizumab, an investigational or licensed
- •biosimilar of tocilizumab or any interleukin\-6 acting drugs (approved or investigational).
- •4\. Prior use of targeted synthetic disease\-modifying anti\-rheumatic
- •drugs like janus kinase inhibitors
- •5\. Prior use of any biological agent for a condition other than
- •rheumatoid arthritis (e.g., ranibizumab, denosumab).
- •6\. Prior use of more than two biologic treatments for rheumatoid
- •7\. Prior use of biologic investigational drugs (excluding biosimilars) for the treatment of rheumatoid arthritis.
Outcomes
Primary Outcomes
Not specified
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