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Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01181050
First Posted: August 13, 2010
Last Update Posted: October 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
  Purpose
This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).

Condition Intervention Phase
Inflammation Rheumatoid Arthritis Drug: NNC0142-0002 Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Change in DAS28-CRP After 12 Weeks of Treatment [ Time Frame: Week 0, Week 12 ]
    DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.


Secondary Outcome Measures:
  • Change in DAS28-CRP After 6 Weeks of Treatment. [ Time Frame: Week 0, Week 6 ]
    DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.

  • Change in DAS28-CRP After 24 Weeks of Treatment. [ Time Frame: Week 0, Week 24 ]
    DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.


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: 4.0 mg/kg
Subjects received a single dose of 4 mg/kg NNC0142-0002
Drug: NNC0142-0002
A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).
Placebo Comparator: Placebo
Subjects received a single dose of placebo
Drug: placebo
A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of RA meeting the American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
  • Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
  • 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 dosing
  • Ability to be examined by Magnetic Resonance Imaging (MRI)
  • Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs

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/m^2
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181050


Locations
Germany
Berlin, Germany, 13353
Russian Federation
Moscow, Russian Federation, 109240
Ukraine
Kiev, Ukraine, 03680
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01181050     History of Changes
Other Study ID Numbers: NN8555-3796
U1111-1114-9194 ( Other Identifier: WHO )
2010-019261-28 ( EudraCT Number )
First Submitted: August 12, 2010
First Posted: August 13, 2010
Results First Submitted: April 25, 2013
Results First Posted: April 28, 2014
Last Update Posted: October 3, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes


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