A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

Recruitment & Eligibility

Inclusion Criteria

Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010 - Active RA, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. C-reactive protein (CRP) above or equal to 1.0 mg/dL (10 mg/L) - Patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. Methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance b. Hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit

Exclusion Criteria

Patients with arthritis due to other autoimmune diseases than RA - Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) - History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy - Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit - Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant - Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective

Study & Design

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)	At week 12 (responder or non-responder)

Secondary Outcome Measures

Name	Time	Method
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)	At weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response	At weeks 12 and 24
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)	At weeks 12 and 24
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)	Week 52
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)	At weeks 12 and 24
Incidence and type of adverse events (AEs)	Week 52
Change from baseline in van der Heijde modified Sharp score	At weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline	At weeks 12 and 24
ACR20, ACR50 and ACR70 improvement of ACR score from baseline	At weeks 12 and 24

Recruitment & Eligibility