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Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01370902
First received: May 31, 2011
Last updated: May 8, 2013
Last verified: May 2013
History of Changes

May 31, 2011
May 8, 2013
May 2011
March 2014   (final data collection date for primary outcome measure)
Incidence of adverse events [ Time Frame: from trial product administration to week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01370902 on ClinicalTrials.gov Archive Site
  • Antibodies against NNC141-0100 [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ] [ Designated as safety issue: No ]
  • Area under the serum concentration-time curve - SD trial part [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ] [ Designated as safety issue: No ]
  • Terminal half-life (t½) - SD trial part [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ] [ Designated as safety issue: No ]
  • Terminal half-life (t½) - MD trial part [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis
A Randomised, Double-blind, Placebo-controlled, Single-dose and Multiple-dose, Dose-escalation Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0141-0000-0100 in Subjects With Rheumatoid Arthritis

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of single and repeated doses of NNC141-0100 in subjects with Rheumatoid Arthritis.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Inflammation
  • Rheumatoid Arthritis
  • Drug: NNC 0141-0000-0100
    Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
  • Drug: placebo
    Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
  • Drug: NNC 0141-0000-0100
    Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.
  • Drug: placebo
    Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels
  • Drug: NNC 0141-0000-0100
    Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part
  • Drug: placebo
    Single dose administered intravenously (into a vein), as a comparator at all dose levels
  • Experimental: Single-dose (SD) trial part (i.v.)
    Interventions:
    • Drug: NNC 0141-0000-0100
    • Drug: placebo
  • Experimental: Single-dose (SD) trial part (s.c.)
    Interventions:
    • Drug: NNC 0141-0000-0100
    • Drug: placebo
  • Experimental: Multiple-dose (MD) trial part (s.c.)
    Interventions:
    • Drug: NNC 0141-0000-0100
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
92
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • A diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR1987 classification) of at least 3 months duration prior to randomisation
  • Active Rheumatoid Arthritis (RA) characterised by a DAS28-CRP (Disease Activity Score of 28 joints, calculated with CRP (C-reactive protein) value) greater than or equal to 3.2
  • Females must be post-menopausal or surgically sterile (post-menopausal for at least 1 year) or be willing to use highly effective method of birth control
  • Males must be willing to use highly effective contraception
  • Subjects on stable doses of methotrexate (7.5 to 25 mg/week, both inclusive) for at least 4 weeks prior to randomisation
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01370902
NN8765-3658, 2010-019234-28, U1111-1120-2542
No
Novo Nordisk
Novo Nordisk
Not Provided
Study Director: Linda Favre-Kontula Novo Nordisk
Novo Nordisk
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP