Efficacy of NNC 0142-0000-0002 in Subjects With Rheumatoid Arthritis (RA)
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01181050
First received: August 12, 2010
Last updated: May 10, 2012
Last verified: May 2012
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Purpose
This trial is conducted in Europe and Asia. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC 0142-0000-0002 administered to subjects with active rheumatoid arthritis (RA).
| Condition | Intervention | Phase |
|---|---|---|
|
Rheumatoid Arthritis Inflammation |
Drug: NNC 0142-0000-0002 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, Single-dose, Double-blind, Placebocontrolled, Parallel-group Trial to Assess Clinical Efficacy of NNC 0142-0000-0002 in Subjects With Active 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: at week 0, week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in DAS28-CRP (disease activity score 28 calculated with C-reactive protein value) [ Time Frame: at week 0, week 6, week 24 ] [ Designated as safety issue: No ]
| Enrollment: | 63 |
| Study Start Date: | August 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: NNC 0142-0000-0002
A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).
|
| Placebo Comparator: B |
Drug: placebo
A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., 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:
- Diagnosed with RA (rheumatoid arthritis) at least three months prior to trial product administration
- Subjects with active RA (rheumatoid arthritis) having at least three tender and three swollen joints (can be the same), including one swollen wrist or at least two ipsilateral metacarpophalangeal joints
- Concomitant treatment with methotrexate (MTX) 7.5-25 mg/week for at least 12 weeks, with stable dose for at least 4 weeks prior to trial product administration
- Ability to be examined by MRI (magnetic resonance imaging)
Exclusion Criteria:
- Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
- Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
- Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m2
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01181050 History of Changes |
| Other Study ID Numbers: | NN8555-3796, U1111-1114-9194, 2010-019261-28 |
| Study First Received: | August 12, 2010 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Germany: Paul-Ehrlich-Institut Ukraine: Ministry of Health Ukraine Russia: Ministry of Health Russia |
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 23, 2013