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

Purpose

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 repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

Condition	Intervention	Phase
Inflammation Rheumatoid Arthritis	Drug: NNC0109-0012 Drug: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [ Time Frame: At week 12 (responder or non-responder) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR20, ACR50 and ACR70 improvement of ACR score from baseline [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
European League Against Rheumatism (EULAR) criteria response [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Incidence and type of adverse events (AEs) [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
Change from baseline in van der Heijde modified Sharp score [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Incidence and type of adverse events (AEs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	268
Study Start Date:	October 2012
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 60 mg	Drug: NNC0109-0012 Administered subcutaneously (s.c., under the skin), once weekly.
Experimental: 120 mg	Drug: NNC0109-0012 Administered subcutaneously (s.c., under the skin), once weekly.
Experimental: 240 mg	Drug: NNC0109-0012 Administered subcutaneously (s.c., under the skin), once weekly.
Experimental: Placebo	Drug: placebo Administered subcutaneously (s.c., under the skin), once weekly.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636843

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Show 36 Study Locations

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Xavier Valencia

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01636843 History of Changes
Other Study ID Numbers:	NN8226-3613, 2012-000610-11, U1111-1127-9324
Study First Received:	July 6, 2012
Last Updated:	May 14, 2013
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Belgium: Federal Agency for Medicines and Healthcare Products Brazil: Ministry of Health Czech Republic: State Institute for Drug Control France: Ministry of Health Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration Italy: Ministry of Health Mexico: National Institute of Public Health, Health Secretariat Poland: Ministry of Health

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents

Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013