NCT01181050

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Geographic Reach
3 countries

3 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

Study Start

First participant enrolled

August 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 13, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 28, 2014

Completed
Last Updated

October 3, 2016

Status Verified

August 1, 2016

Enrollment Period

1.7 years

First QC Date

August 12, 2010

Results QC Date

April 25, 2013

Last Update Submit

August 24, 2016

Conditions

InflammationRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in DAS28-CRP After 12 Weeks of Treatment

    DAS28-CRP=0.56×sqrt(tender joints \[count:1-28\])+0.28×sqrt(swollen joints \[count:1-28\])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale \[100=most severe\])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.

    Week 0, Week 12

Secondary Outcomes (2)

  • Change in DAS28-CRP After 6 Weeks of Treatment.

    Week 0, Week 6

  • Change in DAS28-CRP After 24 Weeks of Treatment.

    Week 0, Week 24

Study Arms (2)

4.0 mg/kg

EXPERIMENTAL

Subjects received a single dose of 4 mg/kg NNC0142-0002

Drug: NNC0142-0002

Placebo

PLACEBO COMPARATOR

Subjects received a single dose of placebo

Drug: placebo

Interventions

NNC0142-0002DRUG

A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).

4.0 mg/kg
placeboDRUG

A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).

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 American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
  • Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
  • Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
  • Ability to be examined by Magnetic Resonance Imaging (MRI)
  • Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs

You may not qualify if:

  • Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
  • Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
  • Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m\^2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Moscow, 109240, Russia

Location

Unknown Facility

Kiev, 03680, Ukraine

Location

Related Links

MeSH Terms

Conditions

InflammationArthritis, Rheumatoid

Interventions

NNC0142-0002 monoclonal antibody

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

As per protocol, this clinical proof-of-principle trial investigated a limited number of participants and doses (single-dose regimen).

Results Point of Contact

Title
Public Access to Clinical Trials
Organization
Novo Nordisk A/S
RA-RNDUS-ClinTriDisc@ITS.JNJ.com

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2010

First Posted

August 13, 2010

Study Start

August 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 3, 2016

Results First Posted

April 28, 2014

Record last verified: 2016-08

Locations

UA(1)RU(1)DE(1)