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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01565408
Collaborator
(none)
32
Enrollment
5
Locations
2
Arms
19
Duration (Months)
6.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Mar 1, 2012
Actual Primary Completion Date :
Oct 1, 2013
Actual Study Completion Date :
Oct 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Incidence of adverse events (AEs) [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 [Week 1, week 27]

  2. Change in disease activity score 28 calculated using C-reactive protein (DAS28-CRP) [From week 1 to week 9 (8 weeks after initiation of treatment)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Berlin Germany 10117
2 Novo Nordisk Investigational Site Moscow Russian Federation 117556
3 Novo Nordisk Investigational Site Moscow Russian Federation 119435
4 Novo Nordisk Investigational Site Moscow Russian Federation 125284
5 Novo Nordisk Investigational Site Yaroslavl Russian Federation 150003

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01565408
Other Study ID Numbers:
  • NN8828-3841
  • 2011-003037-33
  • U1111-1122-4067
First Posted:
Mar 28, 2012
Last Update Posted:
Feb 8, 2017
Last Verified:
Feb 1, 2017
Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation

Study Results

No Results Posted as of Feb 8, 2017