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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Jan 2011

Geographic Reach

6 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

October 14, 2010

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2010

Completed

2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed

Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

October 14, 2010

Last Update Submit

February 8, 2017

Conditions

Inflammation Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Study Arms (2)

A

EXPERIMENTAL

Drug: NNC 0151-0000-0000

B

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC 0151-0000-0000DRUG

Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period

placeboDRUG

Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.