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

NCT ID: NCT01370902

Last Updated: 2014-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammation Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single-dose (SD) trial part (i.v.)

Group Type EXPERIMENTAL

NNC 0141-0000-0100

Intervention Type DRUG

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

placebo

Intervention Type DRUG

Single dose administered intravenously (into a vein), as a comparator at all dose levels

Single-dose (SD) trial part (s.c.)

Group Type EXPERIMENTAL

NNC 0141-0000-0100

Intervention Type 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

Intervention Type DRUG

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

Multiple-dose (MD) trial part (s.c.)

Group Type EXPERIMENTAL

NNC 0141-0000-0100

Intervention Type DRUG

Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.

placebo

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

placebo

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

Intervention Type 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.

Intervention Type DRUG

placebo

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

Intervention Type 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

Intervention Type DRUG

placebo

Single dose administered intravenously (into a vein), as a comparator at all dose levels

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innate Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renaud Buffet

Role: STUDY_DIRECTOR

Innate Pharma

Locations

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Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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2010-019234-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1120-2542

Identifier Type: OTHER

Identifier Source: secondary_id

NN8765-3658

Identifier Type: -

Identifier Source: org_study_id