2012-02-01 - 2016-12-31
Phase II
終止收納5
ICD-10M05.70
未明示部位類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.711
右側肩部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.712
左側肩部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.719
未明示側性肩部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.721
右側肘部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.722
左側肘部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.729
未明示側性肘部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.731
右側腕部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.732
左側腕部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.739
未明示側性腕部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.741
右側手部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.742
左側手部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.749
未明示側性手部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.751
右側髖部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.752
左側髖部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.759
未明示側性髖部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.761
右側膝部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.762
左側膝部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.769
未明示側性膝部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.771
右側踝部及足部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.772
左側踝部及足部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.779
未明示側性踝部及足部類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.79
多部位類風濕性關節炎伴有類風濕因子，未侵及器官及系統
ICD-10M05.80
未明示部位之其他類風濕性關節炎伴有類風濕因子
ICD-10M05.811
右側肩部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.812
左側肩部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.819
未明示側性肩部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.821
右側肘部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.822
左側肘部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.829
未明示側性肘部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.831
右側腕部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.832
左側腕部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.839
未明示側性腕部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.841
右側手部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.842
左側手部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.849
未明示側性手部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.851
右側髖部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.852
左側髖部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.859
未明示側性髖部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.861
右側膝部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.862
左側膝部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.869
未明示側性膝部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.871
右側踝部及足部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.872
左側踝部及足部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.879
未明示側性踝部及足部其他類風濕性關節炎伴有類風濕因子
ICD-10M05.89
多部位其他類風濕性關節炎伴有類風濕因子
ICD-10M05.9
類風濕性關節炎伴有類風濕因子
ICD-10M06.00
未明示部位類風濕性關節炎未伴有類風濕因子
ICD-10M06.011
右側肩部類風濕性關節炎未伴有類風濕因子
ICD-10M06.012
左側肩部類風濕性關節炎未伴有類風濕因子
ICD-10M06.019
未明示側性肩部類風濕性關節炎未伴有類風濕因子
ICD-10M06.021
右側肘部類風濕性關節炎未伴有類風濕因子
ICD-10M06.022
左側肘部類風濕性關節炎未伴有類風濕因子
ICD-10M06.029
未明示側性肘部類風濕性關節炎未伴有類風濕因子
ICD-10M06.031
右側腕部類風濕性關節炎未伴有類風濕因子
ICD-10M06.032
左側腕部類風濕性關節炎未伴有類風濕因子
ICD-10M06.039
未明示側性腕部類風濕性關節炎未伴有類風濕因子
ICD-10M06.041
右側手部類風濕性關節炎未伴有類風濕因子
ICD-10M06.042
左側手部類風濕性關節炎未伴有類風濕因子
ICD-10M06.049
未明示側性手部類風濕性關節炎未伴有類風濕因子
ICD-10M06.051
右側髖部類風濕性關節炎未伴有類風濕因子
ICD-10M06.052
左側髖部類風濕性關節炎未伴有類風濕因子
ICD-10M06.059
未明示側性髖部類風濕性關節炎未伴有類風濕因子
ICD-10M06.061
右側膝部類風濕性關節炎未伴有類風濕因子
ICD-10M06.062
左側膝部類風濕性關節炎未伴有類風濕因子
ICD-10M06.069
未明示側性膝部類風濕性關節炎未伴有類風濕因子
ICD-10M06.071
右側踝部及足部類風濕性關節炎未伴有類風濕因子
ICD-10M06.072
左側踝部及足部類風濕性關節炎未伴有類風濕因子
ICD-10M06.079
未明示側性踝部及足部側類風濕性關節炎未伴有類風濕因子
ICD-10M06.08
脊椎類風濕性關節炎未伴有類風濕因子
ICD-10M06.09
多部位類風濕性關節炎未伴有類風濕因子
ICD-10M06.1
成年期發作之Still氏病
ICD-10M06.20
未明示部位類風濕性滑液囊炎
ICD-10M06.211
右側肩部類風濕性滑液囊炎
ICD-10M06.212
左側肩部類風濕性滑液囊炎
ICD-10M06.219
未明示側性肩部類風濕性滑液囊炎
ICD-10M06.221
右側肘部類風濕性滑液囊炎
ICD-10M06.222
左側肘部類風濕性滑液囊炎
ICD-10M06.229
未明示側性肘部類風濕性滑液囊炎
ICD-10M06.231
右側腕部類風濕性滑液囊炎
ICD-10M06.232
左側腕部類風濕性滑液囊炎
ICD-10M06.239
未明示側性腕部類風濕性滑液囊炎
ICD-10M06.241
右側手部類風濕性滑液囊炎
ICD-10M06.242
左側手部類風濕性滑液囊炎
ICD-10M06.249
未明示側性手部類風濕性滑液囊炎
ICD-10M06.251
右側髖部類風濕性滑液囊炎
ICD-10M06.252
左側髖部類風濕性滑液囊炎
ICD-10M06.259
未明示側性髖部類風濕性滑液囊炎
ICD-10M06.261
右側膝部類風濕性滑液囊炎
ICD-10M06.262
左側膝部類風濕性滑液囊炎
ICD-10M06.269
未明示側性膝部類風濕性滑液囊炎
ICD-10M06.271
右側踝部及足部類風濕性滑液囊炎
ICD-10M06.272
左側踝部及足部類風濕性滑液囊炎
ICD-10M06.279
未明示側性踝部及足部側類風濕性滑液囊炎
ICD-10M06.28
脊椎類風濕性滑液囊炎
ICD-10M06.29
多部位類風濕性滑液囊炎
ICD-10M06.30
未明示部位類風濕性結節
ICD-10M06.311
右側肩部類風濕性結節
ICD-10M06.312
左側肩部類風濕性結節
ICD-10M06.319
未明示側性肩部類風濕性結節
ICD-10M06.321
右側肘部類風濕性結節
ICD-10M06.322
左側肘部類風濕性結節
ICD-10M06.329
未明示側性肘部類風濕性結節
ICD-10M06.331
右側腕部類風濕性結節
ICD-10M06.332
左側腕部類風濕性結節
ICD-10M06.339
未明示側性腕部類風濕性結節
ICD-10M06.341
右側手部類風濕性結節
ICD-10M06.342
左側手部類風濕性結節
ICD-10M06.349
未明示側性手部類風濕性結節
ICD-10M06.351
右側髖部類風濕性結節
ICD-10M06.352
左側髖部類風濕性結節
ICD-10M06.359
未明示側性髖部類風濕性結節
ICD-10M06.361
右側膝部類風濕性結節
ICD-10M06.362
左側膝部類風濕性結節
ICD-10M06.369
未明示側性膝部類風濕性結節
ICD-10M06.371
右側踝部及足部類風濕性結節
ICD-10M06.372
左側踝部及足部類風濕性結節
ICD-10M06.379
未明示側性踝部及足部側類風濕性結節
ICD-10M06.38
脊椎類風濕性結節
ICD-10M06.39
多部位類風濕性結節
ICD-10M06.80
未明示部位其他特定類風濕性關節炎
ICD-10M06.811
右側肩部其他特定類風濕性關節炎
ICD-10M06.812
左側肩部其他特定類風濕性關節炎
ICD-10M06.819
未明示側性肩部其他特定類風濕性關節炎
ICD-10M06.821
右側肘部其他特定類風濕性關節炎
ICD-10M06.822
左側肘部其他特定類風濕性關節炎
ICD-10M06.829
未明示側性肘部其他特定類風濕性關節炎
ICD-10M06.831
右側腕部其他特定類風濕性關節炎
ICD-10M06.832
左側腕部其他特定類風濕性關節炎
ICD-10M06.839
未明示側性腕部其他特定類風濕性關節炎
ICD-10M06.841
右側手部其他特定類風濕性關節炎
ICD-10M06.842
左側手部其他特定類風濕性關節炎
ICD-10M06.849
未明示側性手部其他特定類風濕性關節炎
ICD-10M06.851
右側髖部其他特定類風濕性關節炎
ICD-10M06.852
左側髖部其他特定類風濕性關節炎
ICD-10M06.859
未明示側性髖部其他特定類風濕性關節炎
ICD-10M06.861
右側膝部其他特定類風濕性關節炎
ICD-10M06.862
左側膝部其他特定類風濕性關節炎
ICD-10M06.869
未明示側性膝部其他特定類風濕性關節炎
ICD-10M06.871
右側踝部及足部其他特定類風濕性關節炎
ICD-10M06.872
左側踝部及足部其他特定類風濕性關節炎
ICD-10M06.879
未明示側性踝部及足部側其他特定類風濕性關節炎
ICD-10M06.88
脊椎其他特定類風濕性關節炎
ICD-10M06.89
多部位其他特定類風濕性關節炎
ICD-10M06.9
類風濕性關節炎
ICD-9714.0
類風濕性關節炎
MULTI-CENTER, OPEN-LABEL, FOLLOW-UP STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY TO ASIAN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO COMPLETED STUDY RA0083
-
試驗申請者
百瑞精鼎國際股份有限公司
-
試驗委託 / 贊助單位名稱
UCB Japan Co. Ltd.
-
臨床試驗規模
多國多中心
-
更新日期
2025/08/20
試驗主持人及試驗醫院
實際收案人數
0 終止收納
實際收案人數
0 終止收納
實際收案人數
0 終止收納
適應症
試驗目的
藥品名稱
主成份
劑型
劑量
評估指標
• AEs
• Vital signs
• Chest x-rays
• Electrocardiograms (ECGs)
• Laboratory parameters
Pharmacokinetic variables
• Plasma concentrations of CDP6038
• Anti-CDP6038 antibodies
Efficacy variables
• Change from Baseline (Week 0 of RA0083) in the DAS28(CRP) at Weeks 12, 24, 48, and 96
• ACR20/50/70 improvement criteria response rates (from Baseline at Week 0 of RA0083)
at Weeks 24, 48, and 96
• Percentage of subjects with DAS28(CRP) <2.6 and with DAS28(CRP) ≤3.2 at Weeks 12, 24, 48, and 96
• Change from Baseline (Week 0 of RA0083) in CDAI and SDAI, at Weeks 48, and 96
Exploratory efficacy variables
The following exploratory efficacy variables will be assessed:
• ACR Core Component changes from Baseline (Week 0 of RA0083) at all time points measured. The components of the Core Set are:
- Tender/painful joint count (TJC) number, an assessment of 68 joints
- Swollen joint count (SJC) number, an assessment of 66 joints
- Patient’s Assessment of Arthritis Pain Visual Analog Scale (VAS) (100mm)
- Patient’s Global Assessment of Disease Activity VAS (100mm)
- Physician’s Global Assessment of Disease Activity VAS (100mm)
- Value of acute phase reactants (CRP in mg/L)
- Health Assessment Questionnaire-Disability Index (HAQ–DI).
• Change from Baseline (Week 0 of RA0083) in the DAS28(CRP) at all time points measured.
• ACR20/50/70 improvement criteria response rates (from Baseline at Week 0 of RA0083) at all time points measured.
• Percentage of subjects with DAS28(CRP) <2.6 and with DAS28(CRP) ≤3.2 at all time points measured.
• Change from Baseline (Week 0 of RA0083) in CDAI and SDAI at all time points measured.
• Change from Baseline (Week 0 of RA0083) in the DAS28(ESR) at Weeks 4 and 12
• Change from Baseline (Week 0 of RA0083) in Bristol Rheumatoid Arthritis Fatigue Multi-Dimensional Questionnaire (BRAF-MDQ) and BRAF Coping-Numeric Rating Scale (BRAF Coping-NRS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and every 24 weeksthereafter until study end
• Patient’s Global Impression of Change (PGIC) at Weeks 4, 8, 12, 24, 48, and every 24 weeks thereafter until study end
• Change from Baseline (Week 0 of RA0083) in Patient Acceptable Symptom State (PASS) at Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, and every 24 weeks thereafter until study end
• Health status as assessed by the EuroQoL-5 Dimensions-3 Level Questionnaire (EQ-5D-3L) at Weeks 4, 8, 12, 24, 32, 40, 48, and every 24 weeks thereafter until study end
主要納入條件
Subjects completing RA0083 are eligible to participate in this study, if all of the following criteria are met:
1. An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the subject.
2. Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator.
3. Subject completed the RA0083 study (Week 12 Visit).
4. Subject must have maintained their stable dose (and route) of MTX between 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan in RA0083, and plan to maintain this same dose and route of administration for at least 12 weeks.
5. Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception (oral/parenteral/implantable hormonal contraceptives, intrauterine device, or barrier and spermicide). Abstinence is not considered an acceptable method of contraception for this study. Female subjects of childbearing potential must agree to use at least 2 forms of adequate contraception during the study and for 6 months (24 weeks) after their last CDP6038 dose. Male subjects must agree to ensure that they or their female partner(s) use adequate contraception during the study and for 12 weeks after the subject receives their last dose of CDP6038.
Exclusion criteria
Subjects are not permitted to enroll in the study if any of the following criteria is met:
1. Subject has an ongoing SAE from the RA0083 study.
2. Female subject of childbearing potential has a positive pregnancy test at Week 12 in RA0083 or plans to become pregnant during the study or within 6 months (24 weeks) following their last dose of IMP.
3. Subject has evidence of active or latent tuberculosis (TB).
4. Subject is receiving any biologic response modifier or synthetic DMARD other than MTX.
5. Subject has planned surgery during the first 12 weeks of the study.
6. Subject with any other condition in RA0083 (eg, clinically significant laboratory values, frequent AEs or SAEs, or infection SAEs) which in the Investigator’s or Sponsor’s judgment would make the subject unsuitable for inclusion in the study.
7. Subjects who tested positive for HBcAb and/or HBsAb at Screening in RA0083 and who subsequently test positive for HBV DNA at Week 12 of RA0083.
試驗計畫預計收納受試者人數
-
台灣人數
40 人
-
全球人數
110 人
