Brief Summary

This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Sep 2012

Shorter than P25 for phase_2

Geographic Reach

7 countries

33 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

July 19, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed

1 month until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed

Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

11 months

First QC Date

July 19, 2012

Last Update Submit

February 6, 2017

Conditions

Inflammation Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP)
Week 0, week 12

Secondary Outcomes (6)

ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Week 12
Incidence of adverse events (AEs)
Up to week 24
Incidence of antibodies against NNC0114-0006
Up to Week 24
Terminal serum half-life (t½)
After second dose administration at week 6
Change in serum levels of total interleukin-21 (IL-21)
Up to week 12
+1 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL

Drug: NNC0114-0006

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC0114-0006DRUG

Two i.v. (intravenous) doses administered 6 weeks apart.

Active

placeboDRUG

Two i.v. (intravenous) doses administered 6 weeks apart.

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

A diagnosis of RA meeting the 2010 ACR (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)
Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count
Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)
Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)

You may not qualify if:

Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m\^2
Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible
Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)
Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy

Contact the study team to confirm eligibility.