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Clinical Trial Results:
A Phase 2, Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate Multiple Dose Levels of IPI- 145 with Background Methotrexate in Subjects with Active Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

Summary
EudraCT number	2012-003724-20
Trial protocol	HU DE BG RO
Global end of trial date	23 Dec 2014

Results information
Results version number	v1
This version publication date	25 May 2016
First version publication date	25 May 2016
Other versions	v2
Summary report(s)	IPI-145-04 CSR Synopsis

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

IPI-145-04

ISRCTN number

US NCT number

NCT01851707

WHO universal trial number (UTN)

U1111-1138-8603

Sponsor organisation name

Infinity Pharmaceuticals, Inc.

Sponsor organisation address

784 Memorial Drive, Cambridge, United States, 02139

Public contact

Shannon Devens, Infinity Pharmaceuticals, Inc, 001 6174531340,

Scientific contact

Claudio Dansky Ulmann, Infinity Pharmaceuticals, Inc, 001 6174531338,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

24 Sep 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

24 Sep 2014

Global end of trial reached?

Yes

Global end of trial date

23 Dec 2014

Was the trial ended prematurely?

Main objective of the trial

Evaluate the efficacy of multiple dose levels of IPI 145 compared to placebo in subjects with moderate-to-severe active rheumatoid arthritis (RA) taking a stable dose of methotrexate (MTX)

Protection of trial subjects

The final study protocol and its amendments, including the final version of the informed consent form (ICF), were approved or given a favorable opinion in writing by an Independent Ethics Committee (IEC) at each clinical trial site. The Principal Investigator had to provide evidence of IEC approval to Infinity before he or she could enroll any subject into the study. The Principal Investigator was responsible for informing the IRB/IEC of any amendment to the protocol. In addition, the IRB/IEC approved all advertising used to recruit subjects for the study. The protocol was re-approved by the IRB/IEC annually. Progress reports and notifications of serious adverse events (SAEs) were provided to the IRB/IEC according to regulations and guidelines.

Background therapy

Methotrexate (MTX): Study subjects must have taken MTX for at least 3 months prior to Screening, with a stable dose and route (between 7.5 and 25.0 mg once per week) from at least 6 weeks prior to dosing (Day 1) to be eligible for inclusion. Once on study, subjects must remain on a stable dose and route of MTX (between 7.5 and 25.0 mg once per week) from Screening through the last study visit (final Follow-up Visit). If the weekly MTX dose is less than 15 mg, then subjects must have a documented history of intolerance or toxicity at doses ≥15 mg per week.

Evidence for comparator

Actual start date of recruitment

30 Apr 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country