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IMAGING | RHEUMATOLOGY | INTERNATIONAL
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Imaging | Rheumatology | International has supervised and coordinated many rheumatology projects since 1989 when the modified Sharp-van der Heijde method for rheumatoid arthritis assessment was first described.  Since the late 1990’s, with the development of new therapies, Imaging | Rheumatology | International has been involved in both registration and non-registration studies. Imaging | Rheumatology | International has a pool of 19 readers experienced in scoring X-rays and MRI in RA, PsA, AS/Axial SpA.  The number of subjects in these various trials ranges from 100 to 1200.  Readings can include both eligibility reads, as well as efficacy readings.  Eligibility readings often require just one reader to confirm eligibility criteria (although sometimes double eligibility reads are performed) whereas the efficacy reads can include between 2 to total 6 timepoints, read in groups of two or more timepoints, by at least two independent readers. A summary of the trial experience is given below.

 


 
overview of registration projects
 

 
 
Number of Compounds 29
Number of Filings Receiving Regulatory Approvals 21/22
Number of Sponsors 29
Number of Study Protocols 58
Number of Total Subjects >113000
Number of Imaging Timepoints Read X-Ray RA:  > 461000
    MRI RA:     >   110
    X-Ray AS:  >   4900
    X-Ray PsA: > 8660
    MRI AS SPARCC:  > 4300
    MRI AS ASspiMRI: > 5700
Number of FDA Advisory Panel Presentations 4
 
 

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  The following projects have been scored, are completed or ongoing and are used for
  registration purposes for both the FDA and EMEA. The projects are listed per drug.
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Adalimumab
 
Rheumatoid Arthritis:
PREMIER with extensions to 10 years
[Sharp van der Heijde method]
Ankylosing Spondylitis
:
 ATLAS (mSASSS)
Subjects with non-radiographic axSpA
[mNY and SPARCC Spine]
 
ALX-0061

Rheumatoid Arthritis:
Phase II
[RAMRIS and Tenosynovitis]
 

Abatacept

Rheumatoid Arthritis:
AMPLE
[Sharp van der Heijde method]
Psoriatic Arthritis

Phase III, subjects with active PsA

[Sharp van der Heijde method for PsA]
 

Apremilast

 

Axial Spondyloarthritis

Phase III, subjects with AS

[mNY , ASAS, Berlin modified ASspiMRI-a, SPARCC, Fatty Lesion Spine and SIJ]
 

ASP015K

 

Rheumatoid Arthritis:

Phase III, Japanese subjects who had an inadequate response to MTX

[Sharp van der Heijde method]
 

Brodalumab

 

Psoriatic Arthritis

Phase III, subjects with PsA who have the presence of at least one erosion

[Sharp van der Heijde method for PsA]
 

Canakinumab

 

Juvenile Rheumatoid Arthritis
Two Phase III trials

[Sharp van der Heijde method for JRA]
 
Certolizumab

Rheumatoid Arthritis:

RAPID1 with extension to 5 years
RAPID2 with extension to 5 years

J-RAPID with extension to 2 years

HIKARI with extension to 2 years

C-OPERA, Phase III early RA

C-EARLY, Phase III, early RA
[Sharp van der Heijde method]

Psoriatic Arthritis

RAPID-PsA with extension to 4 years

[Sharp van der Heijde method for PsA]

Axial Spondyloarthritis:

RAPID-axSpA with extension to 4 years

 [Berlin modified ASspiMRI-a and SPARCC SI]
 
Clazakizumab

Rheumatoid Arthritis:
Phase IIb
[Sharp van der Heijde method]
 

Denosumab

Rheumatoid Arthritis:
DRIVE

 [Sharp van der Heijde method]
 
Etanercept

Rheumatoid Arthritis:

TEMPO with extension to 3 years
COMET with extension to 2 years

Japanese dose finding study
[Sharp van der Heijde method]

Ankylosing Spondylitis:

Longterm AS study trial 312

[mSASSS]
 
Fostamatinib

Rheumatoid Arthritis:

OSKIRA 1: Phase III

OSKIRA 2: Phase III

OSKIRA 3: Phase III

OSKIRA X: Long term extension

[Sharp van der Heijde method]
 
Golimumab

Rheumatoid Arthritis:
GO-BEFORE with extension to 2 years
GO-FORWARD with extension to 2 years
GO-AFTER with extension to 2 years
[Sharp van der Heijde method]
 

Infliximab

Rheumatoid Arthritis:

ATTRACT with extension to 2 years
ASPIRE

[Sharp van der Heijde method]

Psoriatic Arthritis: IMPACT, IMPACT2
[Sharp van der Heijde method for PsA]

Ankylosing Spondylitis

ASSERT
[mSASSS and
Berlin modified ASspiMRI-a]
 
Ixekizumab

Psoriatic Arthritis

Phase III

[Sharp van der Heijde method]
 
Ocrelizumab Rheumatoid Arthritis
FILM

SCRIPT

STAGE 
[Sharp van der Heijde method]
 
Sarilumab

Rheumatoid Arthritis:

MOBILITY

Long term extension study

[Sharp van der Heijde method]
 

Tacrolimus

Rheumatoid Arthritis:
Phase IV study
[Sharp van der Heijde method]
 

Tocilizumab Rheumatoid Arthritis:
SAMURAI with extension to 3 years; 2 international studies
[Sharp van der Heijde method]
 
Tofacitinib

Rheumatoid Arthritis:

ORAL START

ORAL SCAN

Long term extension study

[Sharp van der Heijde method]

Axial Spondyloarthritis

Phase 11, dose ranging study in subjects with active AS

[Berlin modified ASspiMRI-a and SPARCC]

Study in subjects with non-radiographic AxSpA

[mNY , ASAS and SPARCC]
 

Ustekinumab

Axial Spondyloarthritis

Phase III program, subjects with active non-radiographic AxSpA

[mNY , ASAS, Berlin modified ASspiMRI-a, SPARCC]
 
VX-509

Rheumatoid Arthritis:

Phase IIB dose finding study
[Sharp van der Heijde method]
 
 
 


 
overview of non-registration projects
 

 
 
Rheumatoid Arthritis Hydroxychloroquine versus sulfasalazine [Sharp van der Heijde method]
  COBRA therapy versus sulfasalazine monotherapy with extension to 5 years [Sharp van der Heijde method]
  Leflunomide with extension to 2 years [Sharp van der Heijde method]
  EURIDISS with extension to 10 years [Sharp van der Heijde method]
  Combination therapy versus sulfasalazine monotherapy
[Sharp van der Heijde method]
  BARFOT low dose prednisolone group [Sharp van der Heijde method]
  TEAR study [Sharp van der Heijde method]
  CLEAR study [Sharp van der Heijde method]
  YEAR study [Sharp van der Heijde method]
  IDEA study [Sharp van der Heijde method]
  ESCAPE study [Sharp van der Heijde method]
  CATCH study [Sharp van der Heijde method]
  ARCTIC study [Sharp van der Heijde method]
  BRASS study [Sharp van der Heijde method]
  SERA study [Sharp van der Heijde method]
  TASER study [Sharp van der Heijde method]
     
Ankylosing Spondylitis OASIS cohort [mSASSS]
  SCQM [mSASSS]
     
 
Imaging | Rheumatology | International consults with pharmaceutical companies, academic centers as well as imaging core labs.   A list of imaging core labs is below:
     
BioClinica www.bioclinica.com/imaging
Parexel Informatics www.parexel.com/imaging