A trial of NNC0109-0012, an anti-IL-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to Methotrexate

• Conditions: Rheumatoid arthritis; MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-000610-11-IT
• Lead Sponsor: OVO NORDISK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-25
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 268

Inclusion Criteria

1. 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 2. Age between 18 and 75 years (both years inclusive) 3. 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. 4. Active RA, characterised by: a. > 5 tender and > 5 swollen joints based on a 28 joint count b. CRP = 1.0 mg/dL (10 mg/L) 5. Patients can be on methotrexate with or without hydroxychloroquine/chloroquine a. Methotrexate treatment (= 15.0 mg/week) for at least 16 weeks, (= 15.0 mg/week 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 p.o.) or chloroquine (250- 500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 238
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Patients with arthritis due to other autoimmune diseases than RA 2. 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) 3. 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 4. 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 5. Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant 6. 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

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