NCT01410695 is a Phase 2/Phase 3 clinical trial of masitinib 3 mg in Rheumatoid Arthritis (RA), sponsored by AB Science.

Who is sponsoring NCT01410695?

NCT01410695 is sponsored by AB Science.

What drugs are being tested in NCT01410695?

Interventions in NCT01410695: masitinib 3 mg, masitinib 6.0 mg, methotrexate, Placebo (methotrexate), Placebo (masitinib).

What condition does NCT01410695 study?

NCT01410695 studies Rheumatoid Arthritis (RA).

Is NCT01410695 still recruiting?

NCT01410695 is currently terminated. Last updated 13 December 2018.

Last reviewed 2018-12-13 · How we verify

NCT01410695

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A 24-week With Possible Extension, Prospective, Multicenter, Randomised, Double-blind, Controlled, 3-parallel Groups, Phase 2b/3 Study to Compare Efficacy and Safety of Masitinib at 3 and 6 mg/kg/Day to Methotrexate, With a Randomisation 1:1:1, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including at Least One Biologic Drug if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Biologic Drugs

Terminated Phase 2/Phase 3 Last updated 13 December 2018

What this trial tests

Phase 2/Phase 3 trial testing masitinib 3 mg in Rheumatoid Arthritis (RA) in 324 participants. Terminated before completion.

Timeline

1 July 2011

Primary endpoint
1 October 2015

1 October 2015

Quick facts

Lead sponsor	AB Science
Phase	Phase 2/Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	324
Start date	1 July 2011
Primary completion	1 October 2015
Estimated completion	1 October 2015
Sites	1 location across Czechia

Drugs / interventions tested

masitinib 3 mg — full drug profile →
masitinib 6.0 mg — full drug profile →
methotrexate — full drug profile →
Placebo (methotrexate)
Placebo (masitinib) — full drug profile →

Conditions studied

Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →

Sponsor

AB Science — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis (RA). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

ACR50
Time frame: week 24

Sponsor's own description

The objective is to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis (RA)

Currently open trials in the same condition.

NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
NCT07438652 — Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT · NA · recruiting
NCT07264101 — Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis · recruiting
NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
NCT07100873 — A Phase 1 Study of ADI-001 in Rheumatoid Arthritis · Phase 1 · recruiting

Other AB Science trials

Trials by the same sponsor.

NCT07174492 — Efficacy and Safety of Masitinib in Combination With SoC Versus Placebo in the Treatment of ALS Patients · Phase 3 · not yet recruiting
NCT05449444 — Masitinib for the Treatment of Severe Mast Cell Activation Syndrome · Phase 2 · unknown
NCT05200169 — Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects · EARLY_PHASE1 · completed
NCT00789633 — Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01410695 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AB Science
Last refreshed: 13 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01410695.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing