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

Phase 2

Terminated

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: NNC0109-0012

• Registration Number: NCT01636817
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-10
• Study Start: 2012-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2018-09
• Disposition First Submitted: 2018-09-03
• Disposition First Submitted QC: 2018-09-03
• Last Update Submitted: 2018-09-03
• Disposition First Posted: 2018-09-05
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 239

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. above 5 tender and above 5 swollen joints based on a 28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
• Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
60 mg	NNC0109-0012	-
240 mg	NNC0109-0012	-
120 mg	NNC0109-0012	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence and type of adverse events (AEs)	Week 52
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)	At Weeks 12 and 24
20%/50%/or 70% improvement of ACR score from baseline	At Weeks 12 and 24
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)	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
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 van der Heijde modified sharp score	At Weeks 12 and 24
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)	Week 52

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Wolverhampton, United Kingdom