A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1,821
- 主要终点
- Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
研究概览
简要总结
It is known from the COMET-trial that patients who start Enbrel treatment early have a great chance of reaching clinical remission and radiographic nonprogression. It is still unclear, however, how many patients with early arthritis achieve remission and radiographic nonprogression under the conditions of routine rheumatologic care and the local recommendations of Enbrel treatment (pre-treatment of at least 2 DMARDs, one of them MTX).
Therefore, no robust x-ray data are available to show/demonstrate
- the average extent of x-ray damage in routine patients on Enbrel outside clinical studies.
- if the outstanding effect on structural damage of Enbrel can be reproduced in routine practice.
- that the 'Silent Progressor' is an issue relevant not only in clinical trials, but also for day-to-day decision making.
- the optimal onset of Enbrel treatment in the course of the disease to prevent radiographic damage
详细描述
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study.
- •Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study is a requirement for inclusion into this study.
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Definitive diagnosis of RA or PsA.
- •Eligible for Etanercept treatment according to Summary of Product Characteristics (SmPC).
- •Inclusion of subjects pretreated with other biologics other than Etanercept is possible
- •One plain radiograph of hands and feet (Anteroposterior) within 3 month prior to initiation of treatment with Etanercept and one planned consecutive radiograph of hand and feet taken over 12 to 18 months according to German recommendations for patients treated with biologics.
排除标准
- •Receipt of any investigational drug within 3 months of study inclusion.
- •Exclusion Criteria according to the Enbrel® SmPC, with particular attention to:
- •Hypersensitivity to the active substance (etanercept) or to any of the excipients.
- •Sepsis or risk of sepsis.
- •Active infections, including chronic or localised infections.
- •Subjects who have received any previous treatment with etanercept
- •Subjects who are investigational site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
研究组 & 干预措施
Patients with Rheumatoid Arthritis
干预措施: Etanercept (Drug)
Patients with Psoriasis Arthritis
干预措施: Etanercept (Drug)
结局指标
主要结局
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS
时间窗: Baseline, Week 156
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score (mTSS) or Adapted mTSS at End of Phase 1 (Week 78): Efficacy Analysis Set (EAS)
时间窗: Baseline, Week 78
To assess radiological damage mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 1 (Week 78): Completer Analysis Set (CAS)
时间窗: Baseline, Week 78
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS
时间窗: Baseline, Week 156
To assess radiological damage, mTSS score was used in participants with rheumatoid arthritis and mTSS adapted score was used in participants with psoriatic arthritis. Radiographs of the hands and feet were assessed by central raters. Total mTSS score range was 0 (no radiological damage) to 448 (extreme radiological damage); and total mTSS adapted score range was 0 (no radiological damage) to 528 (extreme radiological damage), where higher mTSS and mTSS adapted scores indicate a worse health status in participants with rheumatoid arthritis and participants with psoriatic arthritis, respectively.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS
时间窗: Pre-treatment, Week 78
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS
时间窗: Pre-treatment, Week 156
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS
时间窗: Pre-treatment, Week 156
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (\>0.5), no change (-0.5 to 0.5) and decrease (\<-0.5). Participants with no change or a decrease were considered to be in radiographic remission.
Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS
时间窗: Pre-treatment, Week 78
The normalized change in total scores (mTSS or mTSS adapted) were computed as normalized per year (normalized progression). The change of normalized progression was classified as: increase (greater than \[\>\] 0.5), no change (-0.5 to 0.5) and decrease (less than \[\<\] -0.5). Participants with no change or a decrease were considered to be in radiographic remission.
次要结局
- Linear Relationship Between Normalized Radiographic Progression and Disease Duration(Baseline up to Week 78)
- Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication(Baseline up to Week 78)
- Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF)(Baseline up to Week 78)
- Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28)(Baseline up to Week 78)
- Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics(Baseline up to Week 78)
- Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)(Baseline, Week 78, 156)
- Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156)(Baseline, Week 78, 156)
- Change From Baseline in Simple Disease Activity Index (SDAI) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Rheumatoid Arthritis(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI)(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D)(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Duration of Morning Stiffness in Participants With Temporary Rigidity(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis(Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156)
- Number of Participants With Use of Glucocorticoids and Disease Modifying Antirheumatic Drugs (DMARDs) Baseline Versus Phase 1 (Week 78) and Baseline Versus Phase 2 (Week 156)(Baseline, Week 78, 156)
- Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept(Baseline up to Week 156)
- Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D)(Baseline up to Week 156)