NCT02504671|CompletedPhase 2Results

Study to Evaluate the Efficacy and Safety of GSK3196165 Plus Methotrexate in Subjects With Active Moderate-Severe Rheumatoid Arthritis

A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination With Methotrexate Therapy, in Subjects With Active Moderate-Severe Rheumatoid Arthritis Despite Treatment With Methotrexate

GlaxoSmithKline ClinicalTrials.gov

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2 other identifiers

2017552014-003453-34

Study Type

interventional

Target

222

Locations

13 countries

Sites

Timeline

RegisteredJul 2015

StartedJul 2015

CompletionDec 2017

Brief Summary

This is a randomised, Phase IIb, dose-adaptive, multicentre, double-blind, parallel group, placebo-controlled study with the primary objective to assess the efficacy of GSK3196165, in combination with methotrexate (MTX), in subjects with active moderate severe rheumatoid arthritis (RA) despite treatment with MTX. Approximately 210 subjects will be randomised into the study, following a screening period of up to four weeks. The total treatment period is up to 52 weeks, with a 12-week follow-up period after the last dose (Week 50). Subjects will be randomised (1:1:1:1:1:1) to placebo or one of five subcutaneous (SC) GSK3196165 doses, in combination with MTX (at a weekly dose between 15-25 milligram \[mg\]), previously received for at least 12 weeks, with a stable and tolerated dose and route of administration for \>=4 weeks. Escape therapy is provided at specified timepoints in the protocol for subjects that do not achieve adequate disease improvement.

Trial Health

On Track

Trial Health Score

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

Enrollment

222

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jul 2015

Geographic Reach

13 countries

62 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

2.4 years study duration

First Submitted

Initial submission to the registry

July 20, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed

1 day until next milestone

Study Start

First participant enrolled

July 23, 2015

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2017

Completed

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

April 4, 2019

Completed

Last Updated

January 11, 2021

Status Verified

December 1, 2020

Enrollment Period

2.4 years

First QC Date

July 20, 2015

Results QC Date

December 11, 2018

Last Update Submit

December 10, 2020

Conditions

Arthritis, Rheumatoid

Keywords

DMARD-IRGSK3196165Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Achieved Disease Activity Score for 28 Different Joints With C-reactive Protein Value (DAS28{CRP}) Remission (DAS28 <2.6) at Week 24
DAS28 is a modification of the original DAS and is based on a count of 28 swollen and tender joints and is used to evaluate a participant's response to treatment. DAS 28 CRP utilizing joint scores from the following 28 joints: elbows, shoulders, elbow, wrists, metacarpal- phalangeal I-V, proximal interphalangeal I-V and knees and is calculated using the following formula: DAS28 (CRP) = 0.56\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96. Where TJC - Tender joint Count, SJC= Swollen Joint Count, (GH=participant assessment of disease activity using a 100 millimeter \[mm\] visual analogue scale with 0 = best, 100 = worst) and CRP= C reactive Protein (in \[milligrams/liter\] mg/L). It ranges between 0.96 and 8.61. High score (worse outcome) and low scores (better outcome). ITT population comprised of all participants who were randomized to treatment and who received at least one dose of study treatment (GSK3196165 or placebo).
Week 24

Secondary Outcomes (21)

Change From Baseline in DAS28(CRP) at Week 12
Baseline and Week 12
Percentage of Participants Who Achieved DAS28(CRP) Remission (DAS28 <2.6) at All Time Points
Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
Change From Baseline in DAS28(CRP) at All Assessment Time Points
Baseline and Weeks 1, 2, 4, 6, 8, 12, 16, 20 and 24
Time to First DAS28(CRP) Remission
Up to Week 62
Percentage of Participants Achieving Categorical DAS28(CRP) Response (Moderate/Good [European League Against Rheumatism] EULAR Response) at All Assessment Time Points
Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Week 62 (follow-up)
+16 more secondary outcomes

Study Arms (6)

GSK3196165, Dose 1 + MTX and Folic acid

EXPERIMENTAL

Subject will receive GSK3196165 Dose 1 (initially weekly, then every other week) in combination with MTX (at a dose between 15-25 mg/week) and folic acid \>=5 mg/week.