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A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Primary Purpose

Inflammation, Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NNC 0151-0000-0000
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CZ: Age between 18 and 65 years (both inclusive)
  • A diagnosis of rheumatoid arthritis of at least three months before entry in trial
  • Active rheumatoid arthritis (RA)
  • Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse events (AEs)

Secondary Outcome Measures

Serum concentrations of NNC 151-0000-0000

Full Information

First Posted
October 14, 2010
Last Updated
February 8, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01223911
Brief Title
A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
Official Title
A Randomised, Double-blind, Placebo-controlled, Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NNC 0151-0000-0000
Intervention Description
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
Primary Outcome Measure Information:
Title
Number of adverse events (AEs)
Time Frame
at all scheduled visits (week 1 - week 11)
Secondary Outcome Measure Information:
Title
Serum concentrations of NNC 151-0000-0000
Time Frame
at 48 hours after all dose administrations

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CZ: Age between 18 and 65 years (both inclusive) A diagnosis of rheumatoid arthritis of at least three months before entry in trial Active rheumatoid arthritis (RA) Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration Exclusion Criteria: Known or suspected allergy to trial product or related products Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czech Republic
Facility Name
Novo Nordisk Investigational Site
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Novo Nordisk Investigational Site
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Krakow
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Poznan
ZIP/Postal Code
61-218
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Sfantu Gheorghe
State/Province
Covasna
ZIP/Postal Code
520064
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bacau
ZIP/Postal Code
600114
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
011172
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
Facility Name
Novo Nordisk Investigational Site
City
Burslem
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Citations:
Citation
Daniluk S, Skrumsager BK, Leszczynski P. Safety and tolerability of the anti-C5aR humanised monoclonal antibody NNC0151-0000 in patients with rheumatoid arthritis: A phase 2, randomised, double-blind, placebocontrolled, multiple-dose trial. EULAR (European League Against Rheumatism) 2014; Country: France City: Paris
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

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