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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01370902
First received: May 31, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This trial is conducted in Europe. The aim of this dose-escalating trial is to assess the 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.


Condition Intervention Phase
Inflammation
Rheumatoid Arthritis
Drug: NNC 0141-0000-0100
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: from trial product administration to week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 92
Study Start Date: May 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-dose (SD) trial part (i.v.) 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 (s.c.) 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
Experimental: Multiple-dose (MD) trial part (s.c.) 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01370902

Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Linda Favre-Kontula Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01370902     History of Changes
Other Study ID Numbers: NN8765-3658, 2010-019234-28, U1111-1120-2542
Study First Received: May 31, 2011
Last Updated: March 31, 2014
Health Authority: Germany: Federal Institute for Vaccines and Biomedicines; Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2014