NCT01636817|TerminatedPhase 2

A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN8226-36122012-000609-58U1111-1127-9273

Study Type

interventional

Target

239

Locations

13 countries

Sites

164

Timeline

RegisteredJul 2012

StartedAug 2012

CompletionNov 2014

Brief Summary

This trial is conducted in Europe, North America and South America. The aim of this trial is to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa biologics and are on a stable background of methotrexate (MTX) therapy.

Trial Health

Monitor

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

239

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2012

Geographic Reach

13 countries

164 active sites

Status

terminated

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

2.3 years study duration

First Submitted

Initial submission to the registry

July 6, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed

22 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed

Last Updated

September 5, 2018

Status Verified

September 1, 2018

Enrollment Period

2.3 years

First QC Date

July 6, 2012

Last Update Submit

September 3, 2018

Conditions

Inflammation Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
At Week 12 (i.e., responder or non-responder)

Secondary Outcomes (10)

20%/50%/or 70% improvement of ACR score from baseline
At Weeks 12 and 24
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
At Weeks 12 and 24
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
At Weeks 12 and 24
European League Against Rheumatism (EULAR) criteria response
At Weeks 12 and 24
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
At Weeks 12 and 24
+5 more secondary outcomes

Study Arms (4)

60 mg

EXPERIMENTAL

Drug: NNC0109-0012

120 mg

EXPERIMENTAL

Drug: NNC0109-0012

240 mg

EXPERIMENTAL

Drug: NNC0109-0012

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

NNC0109-0012DRUG

Administered subcutaneously (s.c., under the skin) once weekly.

120 mg240 mg60 mg

placeboDRUG

Administered subcutaneously (s.c., under the skin) once weekly.

Placebo

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

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

You may qualify if:

Informed consent must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
A documented diagnosis of RA at least 6 months prior to screening visit, according to the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria (ACR 1987) if diagnosis was made earlier than 2010
Active RA, characterised by: a. above 5 tender and above 5 swollen joints based on a 28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)
Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at least one but not more than two anti-TNF biologics with active disease documented in medical records at the time of discontinuation

You may not qualify if:

Patients with arthritis due to other autoimmune diseases than RA
Any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
History of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
Patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
Females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
Any other disease or clinically significant abnormality in laboratory parameters which, according to the Investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective

Contact the study team to confirm eligibility.