Clinical Trials List
2012-01-01 - 2018-12-31
Phase II
Terminated8
ICD-10M05.70
Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement
ICD-10M05.711
Rheumatoid arthritis with rheumatoid factor of right shoulder without organ or systems involvement
ICD-10M05.712
Rheumatoid arthritis with rheumatoid factor of left shoulder without organ or systems involvement
ICD-10M05.719
Rheumatoid arthritis with rheumatoid factor of unspecified shoulder without organ or systems involvement
ICD-10M05.721
Rheumatoid arthritis with rheumatoid factor of right elbow without organ or systems involvement
ICD-10M05.722
Rheumatoid arthritis with rheumatoid factor of left elbow without organ or systems involvement
ICD-10M05.729
Rheumatoid arthritis with rheumatoid factor of unspecified elbow without organ or systems involvement
ICD-10M05.731
Rheumatoid arthritis with rheumatoid factor of right wrist without organ or systems involvement
ICD-10M05.732
Rheumatoid arthritis with rheumatoid factor of left wrist without organ or systems involvement
ICD-10M05.739
Rheumatoid arthritis with rheumatoid factor of unspecified wrist without organ or systems involvement
ICD-10M05.741
Rheumatoid arthritis with rheumatoid factor of right hand without organ or systems involvement
ICD-10M05.742
Rheumatoid arthritis with rheumatoid factor of left hand without organ or systems involvement
ICD-10M05.749
Rheumatoid arthritis with rheumatoid factor of unspecified hand without organ or systems involvement
ICD-10M05.751
Rheumatoid arthritis with rheumatoid factor of right hip without organ or systems involvement
ICD-10M05.752
Rheumatoid arthritis with rheumatoid factor of left hip without organ or systems involvement
ICD-10M05.759
Rheumatoid arthritis with rheumatoid factor of unspecified hip without organ or systems involvement
ICD-10M05.761
Rheumatoid arthritis with rheumatoid factor of right knee without organ or systems involvement
ICD-10M05.762
Rheumatoid arthritis with rheumatoid factor of left knee without organ or systems involvement
ICD-10M05.769
Rheumatoid arthritis with rheumatoid factor of unspecified knee without organ or systems involvement
ICD-10M05.771
Rheumatoid arthritis with rheumatoid factor of right ankle and foot without organ or systems involvement
ICD-10M05.772
Rheumatoid arthritis with rheumatoid factor of left ankle and foot without organ or systems involvement
ICD-10M05.779
Rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot without organ or systems involvement
ICD-10M05.79
Rheumatoid arthritis with rheumatoid factor of multiple sites without organ or systems involvement
ICD-10M05.80
Other rheumatoid arthritis with rheumatoid factor of unspecified site
ICD-10M05.811
Other rheumatoid arthritis with rheumatoid factor of right shoulder
ICD-10M05.812
Other rheumatoid arthritis with rheumatoid factor of left shoulder
ICD-10M05.819
Other rheumatoid arthritis with rheumatoid factor of unspecified shoulder
ICD-10M05.821
Other rheumatoid arthritis with rheumatoid factor of right elbow
ICD-10M05.822
Other rheumatoid arthritis with rheumatoid factor of left elbow
ICD-10M05.829
Other rheumatoid arthritis with rheumatoid factor of unspecified elbow
ICD-10M05.831
Other rheumatoid arthritis with rheumatoid factor of right wrist
ICD-10M05.832
Other rheumatoid arthritis with rheumatoid factor of left wrist
ICD-10M05.839
Other rheumatoid arthritis with rheumatoid factor of unspecified wrist
ICD-10M05.841
Other rheumatoid arthritis with rheumatoid factor of right hand
ICD-10M05.842
Other rheumatoid arthritis with rheumatoid factor of left hand
ICD-10M05.849
Other rheumatoid arthritis with rheumatoid factor of unspecified hand
ICD-10M05.851
Other rheumatoid arthritis with rheumatoid factor of right hip
ICD-10M05.852
Other rheumatoid arthritis with rheumatoid factor of left hip
ICD-10M05.859
Other rheumatoid arthritis with rheumatoid factor of unspecified hip
ICD-10M05.861
Other rheumatoid arthritis with rheumatoid factor of right knee
ICD-10M05.862
Other rheumatoid arthritis with rheumatoid factor of left knee
ICD-10M05.869
Other rheumatoid arthritis with rheumatoid factor of unspecified knee
ICD-10M05.871
Other rheumatoid arthritis with rheumatoid factor of right ankle and foot
ICD-10M05.872
Other rheumatoid arthritis with rheumatoid factor of left ankle and foot
ICD-10M05.879
Other rheumatoid arthritis with rheumatoid factor of unspecified ankle and foot
ICD-10M05.89
Other rheumatoid arthritis with rheumatoid factor of multiple sites
ICD-10M05.9
Rheumatoid arthritis with rheumatoid factor, unspecified
ICD-10M06.00
Rheumatoid arthritis without rheumatoid factor, unspecified site
ICD-10M06.011
Rheumatoid arthritis without rheumatoid factor, right shoulder
ICD-10M06.012
Rheumatoid arthritis without rheumatoid factor, left shoulder
ICD-10M06.019
Rheumatoid arthritis without rheumatoid factor, unspecified shoulder
ICD-10M06.021
Rheumatoid arthritis without rheumatoid factor, right elbow
ICD-10M06.022
Rheumatoid arthritis without rheumatoid factor, left elbow
ICD-10M06.029
Rheumatoid arthritis without rheumatoid factor, unspecified elbow
ICD-10M06.031
Rheumatoid arthritis without rheumatoid factor, right wrist
ICD-10M06.032
Rheumatoid arthritis without rheumatoid factor, left wrist
ICD-10M06.039
Rheumatoid arthritis without rheumatoid factor, unspecified wrist
ICD-10M06.041
Rheumatoid arthritis without rheumatoid factor, right hand
ICD-10M06.042
Rheumatoid arthritis without rheumatoid factor, left hand
ICD-10M06.049
Rheumatoid arthritis without rheumatoid factor, unspecified hand
ICD-10M06.051
Rheumatoid arthritis without rheumatoid factor, right hip
ICD-10M06.052
Rheumatoid arthritis without rheumatoid factor, left hip
ICD-10M06.059
Rheumatoid arthritis without rheumatoid factor, unspecified hip
ICD-10M06.061
Rheumatoid arthritis without rheumatoid factor, right knee
ICD-10M06.062
Rheumatoid arthritis without rheumatoid factor, left knee
ICD-10M06.069
Rheumatoid arthritis without rheumatoid factor, unspecified knee
ICD-10M06.071
Rheumatoid arthritis without rheumatoid factor, right ankle and foot
ICD-10M06.072
Rheumatoid arthritis without rheumatoid factor, left ankle and foot
ICD-10M06.079
Rheumatoid arthritis without rheumatoid factor, unspecified ankle and foot
ICD-10M06.08
Rheumatoid arthritis without rheumatoid factor, vertebrae
ICD-10M06.09
Rheumatoid arthritis without rheumatoid factor, multiple sites
ICD-10M06.1
Adult-onset Still's disease
ICD-10M06.20
Rheumatoid bursitis, unspecified site
ICD-10M06.211
Rheumatoid bursitis, right shoulder
ICD-10M06.212
Rheumatoid bursitis, left shoulder
ICD-10M06.219
Rheumatoid bursitis, unspecified shoulder
ICD-10M06.221
Rheumatoid bursitis, right elbow
ICD-10M06.222
Rheumatoid bursitis, left elbow
ICD-10M06.229
Rheumatoid bursitis, unspecified elbow
ICD-10M06.231
Rheumatoid bursitis, right wrist
ICD-10M06.232
Rheumatoid bursitis, left wrist
ICD-10M06.239
Rheumatoid bursitis, unspecified wrist
ICD-10M06.241
Rheumatoid bursitis, right hand
ICD-10M06.242
Rheumatoid bursitis, left hand
ICD-10M06.249
Rheumatoid bursitis, unspecified hand
ICD-10M06.251
Rheumatoid bursitis, right hip
ICD-10M06.252
Rheumatoid bursitis, left hip
ICD-10M06.259
Rheumatoid bursitis, unspecified hip
ICD-10M06.261
Rheumatoid bursitis, right knee
ICD-10M06.262
Rheumatoid bursitis, left knee
ICD-10M06.269
Rheumatoid bursitis, unspecified knee
ICD-10M06.271
Rheumatoid bursitis, right ankle and foot
ICD-10M06.272
Rheumatoid bursitis, left ankle and foot
ICD-10M06.279
Rheumatoid bursitis, unspecified ankle and foot
ICD-10M06.28
Rheumatoid bursitis, vertebrae
ICD-10M06.29
Rheumatoid bursitis, multiple sites
ICD-10M06.30
Rheumatoid nodule, unspecified site
ICD-10M06.311
Rheumatoid nodule, right shoulder
ICD-10M06.312
Rheumatoid nodule, left shoulder
ICD-10M06.319
Rheumatoid nodule, unspecified shoulder
ICD-10M06.321
Rheumatoid nodule, right elbow
ICD-10M06.322
Rheumatoid nodule, left elbow
ICD-10M06.329
Rheumatoid nodule, unspecified elbow
ICD-10M06.331
Rheumatoid nodule, right wrist
ICD-10M06.332
Rheumatoid nodule, left wrist
ICD-10M06.339
Rheumatoid nodule, unspecified wrist
ICD-10M06.341
Rheumatoid nodule, right hand
ICD-10M06.342
Rheumatoid nodule, left hand
ICD-10M06.349
Rheumatoid nodule, unspecified hand
ICD-10M06.351
Rheumatoid nodule, right hip
ICD-10M06.352
Rheumatoid nodule, left hip
ICD-10M06.359
Rheumatoid nodule, unspecified hip
ICD-10M06.361
Rheumatoid nodule, right knee
ICD-10M06.362
Rheumatoid nodule, left knee
ICD-10M06.369
Rheumatoid nodule, unspecified knee
ICD-10M06.371
Rheumatoid nodule, right ankle and foot
ICD-10M06.372
Rheumatoid nodule, left ankle and foot
ICD-10M06.379
Rheumatoid nodule, unspecified ankle and foot
ICD-10M06.38
Rheumatoid nodule, vertebrae
ICD-10M06.39
Rheumatoid nodule, multiple sites
ICD-10M06.80
Other specified rheumatoid arthritis, unspecified site
ICD-10M06.811
Other specified rheumatoid arthritis, right shoulder
ICD-10M06.812
Other specified rheumatoid arthritis, left shoulder
ICD-10M06.819
Other specified rheumatoid arthritis, unspecified shoulder
ICD-10M06.821
Other specified rheumatoid arthritis, right elbow
ICD-10M06.822
Other specified rheumatoid arthritis, left elbow
ICD-10M06.829
Other specified rheumatoid arthritis, unspecified elbow
ICD-10M06.831
Other specified rheumatoid arthritis, right wrist
ICD-10M06.832
Other specified rheumatoid arthritis, left wrist
ICD-10M06.839
Other specified rheumatoid arthritis, unspecified wrist
ICD-10M06.841
Other specified rheumatoid arthritis, right hand
ICD-10M06.842
Other specified rheumatoid arthritis, left hand
ICD-10M06.849
Other specified rheumatoid arthritis, unspecified hand
ICD-10M06.851
Other specified rheumatoid arthritis, right hip
ICD-10M06.852
Other specified rheumatoid arthritis, left hip
ICD-10M06.859
Other specified rheumatoid arthritis, unspecified hip
ICD-10M06.861
Other specified rheumatoid arthritis, right knee
ICD-10M06.862
Other specified rheumatoid arthritis, left knee
ICD-10M06.869
Other specified rheumatoid arthritis, unspecified knee
ICD-10M06.871
Other specified rheumatoid arthritis, right ankle and foot
ICD-10M06.872
Other specified rheumatoid arthritis, left ankle and foot
ICD-10M06.879
Other specified rheumatoid arthritis, unspecified ankle and foot
ICD-10M06.88
Other specified rheumatoid arthritis, vertebrae
ICD-10M06.89
Other specified rheumatoid arthritis, multiple sites
ICD-10M06.9
Rheumatoid arthritis, unspecified
ICD-9714.0
Rheumatoid arthritis
(OSKIRA-Asia-1X): A Long-term Study to Assess the Safety of Fostamatinib in the Treatment of Rheumatoid Arthritis in Asia
-
Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- SONG-CHOU HSIEH 無
- CHENG-HAN WU 無
- 吳柏樟 無
- KO-JEN LI 無
- PING-NING HSU 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Jeng-Hsien Yen 無
- 吳正欽 無
- 歐燦騰 無
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Safety outcomes will include AEs, serious AEs, vital signs, number of patients with serious infective events, ECG, clinical chemistry, haematology, urinalysis and physical examination.
Adverse event monitoring will include data review by an independent SRC and independent adjudication of CV events.
Efficacy
• Individual components of ACR response criteria (swollen joint count, tender joint
count, patient’s assessment of pain, patient’s global assessment of disease activity,
physician’s global assessment of disease activity, patient’s assessment of physical
function, as measured by the HAQ-DI, C-reactive protein and erythrocyte sedimentation rate).
• DAS28 score.
• HAQ-DI score.
• SF-36.
Patient reported outcomes
In addition to the HAQ-DI, patient’s global assessment of disease activity Visual Analogue
Scale (VAS) and pain VAS, which are components of the ACR response criteria, SF-36 will
also be assessed.
Inclution Criteria
1. Provision of informed consent prior to any study-specific procedures.
2. Patients who have successfully completed study D4300C00008 and whose disease
is adequately controlled, in the opinion of the Investigator.
Exclusion Criteria
1. Premature withdrawal from study D4300C00008 or in the opinion of the Investigator the patient’s disease is not adequately controlled on current treatment.
2. Development of any of the withdrawal criteria from study D4300C00008, including:
− Any physical symptoms of hepatotoxicity;
− Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or bilirubin rise to a value ≥5 x upper limit of normal (ULN)
− AST or ALT rises to >3 x ULN accompanied by an elevation of total bilirubin >2 x ULN;
− ALT or AST rises to >3 x ULN with the appearance of worsening fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash or
eosinophilia;
− Persistent uncontrolled hypertension despite treatment/dose adjustment (as
defined in Appendix I);
− Persistent or recurrent gastrointestinal (GI) intolerance or dizziness despite dose reduction;
− Significant infection;
− Cancer: any malignant lesion.
3. Females who are pregnant or lactating.
4. Any other clinically significant disease or disorder, which in the opinion of the
Investigator (by its nature or by being inadequately controlled) might put the patient
at risk due to participation in the study, or may influence the results of the study, or
the patient’s ability to participate in the study.
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
150 participants
