Efficacy of NNC 0142-0000-0002 in Subjects With Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01181050
First received: August 12, 2010
Last updated: May 10, 2012
Last verified: May 2012
  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 A/S:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181050

Locations
Germany
Berlin, Germany, 10117
Russian Federation
Moscow, Russian Federation, 119435
Ukraine
Kiev, Ukraine, 03680
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Britta Bysted Novo Nordisk A/S
  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 April 17, 2014