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

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ClinicalTrials.gov Identifier: NCT01181050
Recruitment Status : Completed
First Posted : August 13, 2010
Results First Posted : April 28, 2014
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Inflammation Rheumatoid Arthritis Drug: NNC0142-0002 Drug: placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
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
Study Start Date : August 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

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Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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
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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
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Germany
Berlin, Germany, 13353
Russian Federation
Moscow, Russian Federation, 109240
Ukraine
Kiev, Ukraine, 03680
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01181050    
Other Study ID Numbers: NN8555-3796
U1111-1114-9194 ( Other Identifier: WHO )
2010-019261-28 ( EudraCT Number )
First Posted: August 13, 2010    Key Record Dates
Results First Posted: April 28, 2014
Last Update Posted: October 3, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes