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 16 readers experienced in scoring radiographs and MRI in RA, PsA, AS/axial SpA.

 

The number of subjects in these various trials ranges from 100 to 3000.  Readings can include both eligibility reads, as well as efficacy readings.  Eligibility readings often require just one reader to confirm eligibility criteria (although also double eligibility reads with adjudication 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 non-registration projects

  • Number of Compounds
  • Number of Filings Receiving Regulatory Approvals
  • Number of Sponsors
  • Number of Study Protocols
  • Number of Total Subjects
  • Number of Imaging Timepoints Read

 

 

 

 

 

 

 

  • Number of FDA Advisory Panel Presentations

 

 

 

 

 

 

 

 

 

 

 

  • Adalimumab

 

 

 

 

 

 

 

 

  • ALX-0061

 

 

 

 

  • ABT-981

 

 

 

 

  • Abatacept

 

 

 

 

 

 

 

 

 

 

 

  • Apremilast

 

 

 

 

  • ASP015K

 

 

 

 

 

  • Brodalumab

 

 

 

 

  • Canakinumab

 

 

 

 

  • Certolizumab

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Clazakizumab

 

 

 

 

  • Denosumab

 

 

 

 

 

 

  • Etanercept

 

 

 

 

 

 

 

 

 

 

 

 

 

 

  • Tofacitinib

 

 

 

 

 

 

 

 

 

 

  • Upadacitinib

 

 

 

 

  • Ustekinumab

 

 

 

 

  • VX-509

 

 

 

 

 

 

 

 

 

 

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]
  • BIODAM 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 links are below:

 

Overview of non-registration projects

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.

36

21/22

33

77

> 130194

Radiograph RA: >492308

MRI RA: >110

Radiograph AS: >22800

Radiograph PsA: > 24620

MRI AS ASAS-MRI SIJ: > 8000

MRI AS SPARCC: >10664

MRI AS ASspiMRI: >8212

MRI AS SSS: >1200

4

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]

 

Rheumatoid Arthritis:

Phase II

[RAMRIS and Tenosynovitis]

Hand Osteoarthritis:

PhaseIIa, subjects with erosive hand OA

[Verbruggen, OARSI, Kellgren and Lawrence]

Rheumatoid Arthritis:

AMPLE

[Sharp van der Heijde method]

Phase IIIb, subjects with early RA

[Sharp van der Heijde method]

Phase IV, subjects with active RA

[Sharp van der Heijde method]

Psoriatic Arthritis

Phase III, subjects with active PsA

[Sharp van der Heijde method for PsA]

Axial Spondyloarthritis:

Phase III, subjects with AS

[mNY,2-MRI SIJ, Berlin modified ASspiMRI-a, SPARCC, Fatty Lesion Spine and SIJ]

Rheumatoid Arthritis:

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

[Sharp van der Heijde method]

Psoriatic Arthritis:

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

[Sharp van der Heijde method for PsA]

Juvenile Rheumatoid Arthritis:

Two Phase III trials

[Sharp van der Heijde method for JRA]

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]

Phase IIIb, subjects with active axial spondyloarthritis

[mNY, ASAS-MRI SIJ, SPARCC SIJ, Berlin spine]

Phase III, subjects with active axial spondyloarthritis without radiographic sacroiliitis and objective signs of inflammation

[mNY, ASAS-MRI SIJ, SPARCC SIJ,, Berlin spine]

Phase IIb, subjects with active spondyloarthritis

[mNY, ASAS-MRI SIJ, SPARCC SIJ,, Berlin spine]

Phase IIa, subjects with active spondyloarthritis

[mNY]

Rheumatoid Arthritis:

Phase IIb

[Sharp van der Heijde method]

Rheumatoid Arthritis:

DRIVE

[Sharp van der Heijde method]

DESIRABLE

[Sharp van der Heijde method]

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]

Phase IV, subjects with active axial non-radiographic spondyloarthritis

[mNY, ASAS-MRI SIJ, SPARCC SIJ and spine]

SAMURAI with extension to 3 years; 2 international studies

[Sharp van der Heijde method]

 

Rheumatoid Arthritis:

ORAL START

ORAL SCAN

Long term extension study

[Sharp van der Heijde method]

Axial Spondyloarthritis:

Phase II, dose ranging study in subjects with active AS

[Berlin, modified ASspiMRI-a and SPARCC]

Study in subjects with non-radiographic AxSpA

[mNY , ASAS-MRI SIJ and SPARCC]

Axial Spondyloarthritis:

Phase IIb/III, subjects with active ankylosing spondylitis

[mNY, spine total ankylosis, SPARCC SIJ and spine]

Axial Spondyloarthritis:

Phase III program, subjects with active non-radiographic axSpA

[mNY , ASAS-MRI SIJ, Berlin modified ASspiMRI-a, SPARCC]

Rheumatoid Arthritis:

Phase IIB dose finding study

[Sharp van der Heijde method]

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