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Trial record 3 of 5 for:    NNC0114­-0006

Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01565408
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the safety and tolerability of multiple doses of NNC0114-0006 in subjects with rheumatoid arthritis (RA).

Condition or disease Intervention/treatment Phase
Inflammation Rheumatoid Arthritis Drug: NNC0114-0006 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Tolerability of NNC0114-0006 Following Multiple s.c. Dosing at Escalating Dose Levels in Subjects With Rheumatoid Arthritis
Study Start Date : March 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NNC0114-0006 Drug: NNC0114-0006
Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.

Placebo Comparator: Placebo Drug: placebo
Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: From first administration of trial product (week 1) and up until week 27 ]

Secondary Outcome Measures :
  1. Change in serum levels of total IL-21 from first administration of trial product [ Time Frame: Week 1, week 27 ]
  2. Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP) [ Time Frame: From week 1 to week 9 (8 weeks after initiation of treatment) ]


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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 2010 ACR-EULAR (American College of Rheumatology-European League Against Rheumatism) or the 1987 ACR classification criteria, made at least 4 months prior to trial drug administration
  • Active RA, characterised by a DAS28-CRP equal to or above 4.5 and at least 5 tender and 5 swollen joints
  • Methotrexate (MTX) treatment for at least 16 weeks (dose equal to or above 7.5 mg/week and equal to or below 25 mg/week) at a stable dose for at least 6 weeks prior to dosing
  • Female subjects not pregnant and not nursing

Exclusion Criteria:

  • Subjects with chronic inflammatory autoimmune disease other than RA
  • Any active or ongoing chronic infectious disease requiring systemic anti-infectious treatment within 4 weeks prior to randomisation
  • Body mass index (BMI) below 18.0 or above 35.0 kg/m^2

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): NCT01565408


Locations
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Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10117
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 117556
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119435
Novo Nordisk Investigational Site
Moscow, Russian Federation, 125284
Novo Nordisk Investigational Site
Yaroslavl, Russian Federation, 150003
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Wagner F, Skrumsager B, Fitilev S. Safety and tolerability of NNC0114-0006, an anti-IL-21 monoclonal antibody, at multiple s.c. dose levels in patients with rheumatoid arthritis. Arthritis and Rheumatology; 66 (10 (Supplement)): Abstract 1492

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01565408     History of Changes
Other Study ID Numbers: NN8828-3841
2011-003037-33 ( EudraCT Number )
U1111-1122-4067 ( Other Identifier: WHO )
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
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