Overview of non-registration projects
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]