N/A
N=1,821
Prospective Evaluation of the Radiographic Efficacy of Enbrel
Rheumatoid Arthritis · Psoriasis Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01623752 ↗Enrolled (actual)
1,821
Serious AEs
11.3%
Results posted
Aug 2019
Primary outcome: Primary: 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) — 25.1; 14.7; 0.6; -0.4 Units on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Etanercept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
25.1; 14.7; 0.6; -0.4 | — |
| PRIMARY 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) |
25.3; 14.7; 0.6; -0.5 | — |
| PRIMARY Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS |
1.4; 0.7 | — |
| PRIMARY Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS |
1.4; 0.7 | — |
| PRIMARY Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS |
0.959; 1.056; -0.267; -0.995 | 0.278 |
| PRIMARY Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS |
0.981; 1.080; -0.306; -1.033 | 0.251 |
| PRIMARY Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS |
-0.473; -0.348 | — |
| PRIMARY Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS |
-0.473; -0.348 | — |
| SECONDARY Linear Relationship Between Normalized Radiographic Progression and Disease Duration |
-0.012; -0.050 | 0.675 |
| SECONDARY Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) |
1.326; -1.142; 1.075; 2.448; 0.087; 3.370 | 0.106 |
| SECONDARY Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication |
0.749; -0.339; -0.978; -0.370 | 0.015 sig |
| SECONDARY Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics |
0.235; -0.986; 0.621; -0.170 | 0.489 |
| SECONDARY Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) |
0.716; -0.314; 0.170; -0.507 | 0.364 |
| SECONDARY Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) |
11.1; 4.6; -0.1; -0.3; 0.0; 0.2 | — |
| SECONDARY Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) |
14.0; 10.0; 0.7; -0.1; 1.4; 0.6 | — |
| SECONDARY Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 |
64.99; 68.67; 4.38; 3.45; 5.63; 3.99 | — |
| SECONDARY Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 |
4.63; 4.18; -1.26; -1.23; -1.52; -1.37 | — |
| SECONDARY 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 |
25.64; -11.51; -13.49; -13.98; -14.32; -15.28 | — |
| SECONDARY 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 |
35.88; -20.62; -26.04; -16.00; -17.70; -18.77 | — |
| SECONDARY Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) |
7.0; 36.1; 41.2; 37.8; 38.0; 43.7 | — |
| SECONDARY Percentage of Participants With Rheumatoid Arthritis, With Remission Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) |
0.6; 11.2; 16.0; 19.8; 21.3; 22.8 | — |
| SECONDARY Change From Baseline in Participant Pain Visual Analogue Scale (VAS) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 |
55.93; 57.69; -15.03; -18.20; -18.56; -19.01 | — |
| SECONDARY Change From Baseline in Physician Global Assessment (PhyGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 |
57.28; 55.73; -24.49; -24.97; -29.22; -28.54 | — |
| SECONDARY Change From Baseline in Participant Global Assessment (PtGA) of Disease Activity at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 |
54.69; 56.99; -13.55; -17.13; -17.30; -19.32 | — |
| SECONDARY Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) |
546; 177; 714; 230; 3; 0 | — |
| SECONDARY Duration of Morning Stiffness in Participants With Temporary Rigidity |
1.00; 1.00; 0.50; 0.50; 0.50; 0.50 | — |
| SECONDARY Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis |
203; 123; 41; 20; 247; 82 | — |
| SECONDARY Change From Baseline in Nail Involvement at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis |
3.18; -0.98; -1.64; -1.75; -2.09; -2.38 | — |
| SECONDARY Change From Baseline in Inflamed Dactylitic Digits at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 in Participants With Psoriatic Arthritis |
0.72; -0.39; -0.54; -0.61; -0.69; -0.50 | — |
| SECONDARY 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) |
499; 258; 177; 28; 312; 69 | — |
| SECONDARY Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept |
207; 58; 139; 48; 1; 0 | — |
| SECONDARY Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Quality of Life Parameters Using Health Questionnaire by the EuroQol Group (EQ-5D) |
143; 50; 191; 54; 2; 0 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01623752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.