A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics
This study is currently recruiting participants.
Verified May 2013 by Novo Nordisk
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01636817
First received: July 6, 2012
Last updated: May 15, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 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.
| 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 Anti-TNFa Biologics |
Resource links provided by NLM:
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 (i.e., responder or non-responder) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 20%/50%/or 70% 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 Health Assessment Questionnaire - Disability Index (HAQ-DI) [ 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 ]
- 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: | August 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.
|
| Placebo Comparator: 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. 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
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: NCT01636817
Show 93 Study Locations
Contacts
| Contact: Novo Nordisk | clinicaltrials@novonordisk.com |
Show 93 Study LocationsSponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Xavier Valencia | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT01636817 History of Changes |
| Other Study ID Numbers: | NN8226-3612, 2012-000609-58, U1111-1127-9273 |
| Study First Received: | July 6, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Belgium: Federal Agency for Medicines and Healthcare Products Brazil: National Committee of Ethics in Research France: French National Agency for Health Germany: Federal Institute for Drugs and Medical Devices Hungary: Ministry of Health, Social and Family Affairs Italy: The Italian Medicines Agency Mexico: National Institute of Public Health, Health Secretariat Poland: Ministry of Health and Social Security Spain: Spanish Agency of Medicines and Health Care Products United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Inflammation Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 19, 2013