A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Inflammation; Rheumatoid Arthritis
• Interventions: Drug: placebo; Drug: NNC 0151-0000-0000

• Registration Number: NCT01223911
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-18
• Study First Posted: 2010-10-19
• Study Start: 2011-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Disposition First Submitted: 2013-04-10
• Disposition First Submitted QC: 2013-04-10
• Disposition First Posted: 2013-04-16
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• CZ: Age between 18 and 65 years (both inclusive)
• A diagnosis of rheumatoid arthritis of at least three months before entry in trial
• Active rheumatoid arthritis (RA)
• Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

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Exclusion Criteria

• Known or suspected allergy to trial product or related products
• Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo	-
A	NNC 0151-0000-0000	-

Primary Outcome Measures

Name	Time	Method
Number of adverse events (AEs)	at all scheduled visits (week 1 - week 11)

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of NNC 151-0000-0000	at 48 hours after all dose administrations

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Swansea, United Kingdom