Skip to main content
OpenTrials
Completed

NCT Number: NCT01370902

Safety and Tolerability 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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Inflammation Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, 13353, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC 0141-0000-0100

Drug

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

Placebo

Drug

Single dose administered subcutaneously (under the skin) as a comparator at all dose levels

Primary outcomes

  1. Incidence of adverse events

    Time frame: from trial product administration to week 12

Secondary outcomes

  1. Antibodies against NNC141-0100

    Time frame: from trial product administration until final visit (week 12 or longer if applicable)

  2. 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)

  3. Terminal half-life (t½) - SD trial part

    Time frame: from trial product administration until final visit (week 12 or longer if applicable)

  4. Terminal half-life (t½) - MD trial part

    Time frame: from trial product administration until final visit (week 12 or longer if applicable)

Sponsors and collaborators

Lead sponsor

Innate Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 10, 2011
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.