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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370902
First Posted: June 10, 2011
Last Update Posted: December 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Innate Pharma
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Innate Pharma:

Primary Outcome Measures:
  • Incidence of adverse events [ Time Frame: from trial product administration to week 12 ]

Secondary Outcome Measures:
  • Antibodies against NNC141-0100 [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ]
  • 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) ]
  • Terminal half-life (t½) - SD trial part [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ]
  • Terminal half-life (t½) - MD trial part [ Time Frame: from trial product administration until final visit (week 12 or longer if applicable) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370902


Locations
Germany
Berlin, Germany, 13353
Sponsors and Collaborators
Innate Pharma
Investigators
Study Director: Renaud Buffet Innate Pharma
  More Information

Responsible Party: Innate Pharma
ClinicalTrials.gov Identifier: NCT01370902     History of Changes
Other Study ID Numbers: NN8765-3658
2010-019234-28 ( EudraCT Number )
U1111-1120-2542 ( Other Identifier: WHO )
First Submitted: May 31, 2011
First Posted: June 10, 2011
Last Update Posted: December 23, 2014
Last Verified: December 2014

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