NCT02919475|CompletedPhase 2ResultsFDA Drug

Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis

MOVE-RA

A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)

Akros Pharma Inc.ClinicalTrials.gov

Compare

1 other identifier

AE051-G-13-003

Study Type

interventional

Target

260

Locations

10 countries

Sites

Timeline

RegisteredSep 2016

StartedSep 2016

CompletionJun 2018

Brief Summary

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.

Trial Health

On Track

Trial Health Score

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

Enrollment

260

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline

Completed

Started Sep 2016

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach

10 countries

39 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

1.8 years study duration

Study Start

First participant enrolled

September 14, 2016

Completed

13 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2018

Completed

3 years until next milestone

Results Posted

Study results publicly available

June 14, 2021

Completed

Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

1.8 years

First QC Date

September 27, 2016

Results QC Date

March 25, 2021

Last Update Submit

June 11, 2021

Conditions

Rheumatoid Arthritis

Keywords

JTE-051Active Rheumatoid ArthritisEfficacySafetyTolerabilityRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Percentage of Subjects Achieving at Least 20% Improvement From Baseline in American College of Rheumatology (ACR) Core Set Measures (ACR20 Response Rate) Compared to Placebo at End-of-treatment (EOT)
Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at EOT (up to Week 12) compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
Up to 12 Weeks

Secondary Outcomes (9)

Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12
Week 12
Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12
Week 12
Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12
Week 12
Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
Week 12
Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
Week 12
+4 more secondary outcomes