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First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

NCT ID: NCT00927927

Last Updated: 2016-10-03

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-12-31

Brief Summary

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This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.

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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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SD 0.0002 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.0002 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 0.0012 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.0012 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 0.007 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.007 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 0.035 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.035 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 0.175 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.175 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 0.7 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 0.7 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 2.5 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 2.5 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD 7.5 mg/kg

Subjects were injected once with NNC0142-0002 at a dose of 7.5 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

SD Placebo

Subjects were injected once with placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

MD 0.02 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

MD 0.3 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

MD 1.0 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

MD 1.6 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

MD 4.0 mg/kg

Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg

Group Type EXPERIMENTAL

NNC0142-0002

Intervention Type DRUG

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

MD Placebo

Subjects were injected biweekly four times with placebo

Group Type EXPERIMENTAL

placebo

Intervention Type DRUG

Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

Interventions

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NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

NNC0142-0002

Single dose, ranging from 0.0002 mg/kg up to max 7.5 mg/kg, administered subcutaneously (under the skin) on day 1

Intervention Type DRUG

placebo

Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

Intervention Type DRUG

NNC0142-0002

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

Intervention Type DRUG

NNC0142-0002

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

Intervention Type DRUG

NNC0142-0002

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

Intervention Type DRUG

NNC0142-0002

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

Intervention Type DRUG

NNC0142-0002

Multiple dose, ranging from 0.02 mg/kg up to max 4.0 mg/kg, administered subcutaneously (under the skin) four times biweekly

Intervention Type DRUG

placebo

Single dose of 0 mg/kg administered subcutaneously (under the skin); cohort 1-7b on day 1, cohort 8-11 biweekly four times

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Active rheumatoid arthritis, characterized by a Disease Activity Score (DAS28) above 3.2, and a diagnosis of at least three months duration
* Aged between 18 and 75 years (both inclusive)
* Subjects on stable doses of methotrexate for at least 4 weeks prior to dosing
* Use of highly effective contraception during the trial (both males and females)

Exclusion Criteria

* A chronic inflammatory autoimmune or joint disease other than RA (rheumatoid arthritis)
* An active or latent tuberculosis
* Any investigational or experimental therapy within 4 weeks or 5 half-lives (whichever is longer) prior to the screening visit
* A known significant cardio-vascular disease
* Vaccination against live virus or bacteria within 4 weeks prior to randomization
* The use of concomitant medications that are prohibited in the trial (e.g., certain DMARDs (antirheumatic therapies that are disease modifying), biologics (here: biotechnologically produced antibodies), intra-articular corticoid-injections, etc.)
* A positive test result for human immunodeficiency virus (HIV) infection, hepatitis B and/or hepatitis C, or tuberculosis skin test
* Donation of greater than or equal to 400 ml of blood within 8 weeks prior to trial entry
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Britta Væver Bysted, DVM, PhD

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Berlin, , Germany

Site Status

Countries

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Germany

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2008-008703-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN8555-3618

Identifier Type: -

Identifier Source: org_study_id

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