Efficacy of NNC109-0012 in Subjects With Active Rheumatoid Arthritis
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01282255
First received: January 21, 2011
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
This trial is conducted in Europe. The aim of this trial is to evaluate the change in disease activity following 12 weekly s.c. (under the skin) doses of NNC109-0012 compared to placebo in subjects with active Rheumatoid Arthritis (RA).
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Inflammation |
Drug: NNC109-0012 Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double Blind, Placebo-controlled, Multiple Dose Trial of Anti-IL-20 (109-0012) in Subjects With Rheumatoid Arthritis |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value) [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Terminal serum half-life (t½) [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]
- Serum levels of NNC109-0012 [ Time Frame: end of treatment period ] [ Designated as safety issue: No ]
| Enrollment: | 67 |
| Study Start Date: | February 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: NNC109-0012
The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
|
| Placebo Comparator: B |
Drug: placebo
The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Czech Republic: Age between 18 - 65 years (both inclusive)
- A diagnosis of RA made at least 3 months prior to trial start
- Active RA
- Methotrexate treatment (between 7.5 mg and 25 mg/week, both inclusive) for at least 12 weeks with a stable dose for at least 4 weeks prior to trial start
- Female subjects must be willing to avoid pregnancy and breast feeding throughout this trial at least until 15 weeks following the last dose of trial medication
- Male subjects with partners of childbearing potential must be willing to use a highly effective contraception throughout trial incl. a 15 week follow up periode
Exclusion Criteria:
- Known or suspected allergy to trial product or related products
- Body Mass Index (BMI) lower than 18.5 or higher than 35.0 kg/m^2
- Subjects with chronic inflammatory autoimmune disease other than RA (except secondary Sjögren's syndrome or stable hypothyroidism)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01282255
Locations
| Czech Republic | |
| Brno, Czech Republic, 602 00 | |
| Poland | |
| Bytom, Poland, 41-902 | |
| Romania | |
| Cluj-Napoca, Cluj, Romania, 400006 | |
| Spain | |
| Barcelona, Spain, 08036 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Mitzi Eshof | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01282255 History of Changes |
| Other Study ID Numbers: | NN8226-3875, U1111-1117-1136, 2010-021283-14 |
| Study First Received: | January 21, 2011 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Poland: Ministry of Health Romania: National Medicines Agency Italy: Ministry of Health Czech Republic: State Institute for Drug Control Spain: Spanish Agency of Medicines and Health Care Products Portugal: INFARMED Germany: Federal Institute for Drugs and Medicinal Devices (BfarM) United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA) |
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 September 26, 2012
