NCT01973569

Brief Summary

To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
679

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

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

October 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2017

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

December 13, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

October 25, 2013

Results QC Date

September 17, 2019

Last Update Submit

February 3, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisDenosumabRANKLRANKAMG 162joint damageDevelopmental Phase III

Outcome Measures

Primary Outcomes (1)

  • Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo

    Change from baseline in Total Sharp Score (TSS) from baseline to month 12 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.

    baseline to month 12

Secondary Outcomes (6)

  • Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo

    baseline to month 6

  • Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo

    baseline to month 6

  • Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo

    baseline to month 6

  • Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo

    baseline to month 12

  • Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo

    baseline to month 12

  • +1 more secondary outcomes

Study Arms (3)

Denosumab 6 months

EXPERIMENTAL

denosumab administered subcutaneously every 6 months

Drug: denosumab

Denosumab 3 months

EXPERIMENTAL

denosumab administered subcutaneously every 3 months

Drug: denosumab

placebo

PLACEBO COMPARATOR

placebo administered subcutaneously to match denosumab

Drug: placebo

Interventions

denosumabDRUG

denosumab administered subcutaneously

Also known as: AMG 162
Denosumab 3 monthsDenosumab 6 months
placeboDRUG

placebo administered subcutaneously to match denosumab

placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis

You may not qualify if:

  • Functional class IV according by the ACR revised classification (1991)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tokyo, 162-0054, Japan

Location

Related Publications (2)

  • Tanaka Y, Takeuchi T, Soen S, Yamanaka H, Yoneda T, Tanaka S, Nitta T, Okubo N, Genant HK, van der Heijde D. Effects of Denosumab in Japanese Patients With Rheumatoid Arthritis Treated With Conventional Antirheumatic Drugs: 36-month Extension of a Phase III Study. J Rheumatol. 2021 Nov;48(11):1663-1671. doi: 10.3899/jrheum.201376. Epub 2021 Apr 15.

    PMID: 33858976DERIVED

  • Takeuchi T, Soen S, Ishiguro N, Yamanaka H, Tanaka S, Kobayashi M, Okubo N, Nitta T, Tanaka Y. Predictors of new bone erosion in rheumatoid arthritis patients receiving conventional synthetic disease-modifying antirheumatic drugs: Analysis of data from the DRIVE and DESIRABLE studies. Mod Rheumatol. 2021 Jan;31(1):34-41. doi: 10.1080/14397595.2019.1703484. Epub 2020 Jan 9.

    PMID: 31826682DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Denosumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Daiichi Sanyko
Organization
Contact for Clinical Trial Information
dsclinicaltrial@daiichisankyo.co.jp
+81 362251111 (M-F 9-5 JST)

Study Officials

  • Tsutomu Takeuchi, Prof.

    Division of Rheumatology Department of Internal Medicine, Keio University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

October 31, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

September 19, 2017

Last Updated

February 12, 2020

Results First Posted

December 13, 2019

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https:// vivli.org/ourmember/daiichi-sankyo/

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
More information

Locations

JP(1)