--- title: Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice nct_id: NCT02202837 overall_status: COMPLETED sponsor: Pfizer study_type: OBSERVATIONAL primary_condition: Rheumatoid Arthritis countries: Belgium canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02202837.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02202837" ct_last_update_post_date: 2018-12-03 last_seen_at: "2026-05-12T07:12:19.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice **Official Title:** Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Rheumatoid Arthritis Patients Treated With Etanercept (Enbrel (Registered)) **NCT ID:** [NCT02202837](https://clinicaltrials.gov/study/NCT02202837) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 157 - **Lead Sponsor:** Pfizer - **Conditions:** Rheumatoid Arthritis - **Start Date:** 2014-08-12 - **Completion Date:** 2017-04-24 - **CT.gov Last Update:** 2018-12-03 ## Brief Summary Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept ## Detailed Description The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies. This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups. In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria: 1. Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC. 1. First cohort: Etanercept is the first biological product prescribed. 2. Second cohort: Etanercept is the second biological product prescribed. 2. Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed. 3. Eighteen (18) years of age or older at time of consent. Exclusion Criteria: 1\. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent. ``` ## Arms - **Etanercept First** — Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria - **Etanercept second** — Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria ## Interventions - **etanercept** (DRUG) — etanercept 1 x 50 mg/week or 2 x 25mg/week - **etanercept** (DRUG) — etanercept 1 x 50 mg/week or 2 x 25mg/week ## Primary Outcomes - **Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12** _(time frame: Month 6 up to Month 12)_ — DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter \[mg/L\]) or erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \[less than or equal to\] \<=3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 less than (\<) 2.6 implied remission. - **Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12** _(time frame: Month 6 up to Month 12)_ — The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission. - **Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12** _(time frame: Month 6 up to Month 12)_ — The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity. - **Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion** _(time frame: Month 6 up to Month 12)_ — The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1; CRP\<=1 mg/dl; PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). - **Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion** _(time frame: Month 6 up to Month 12)_ — The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1 and PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). - **Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12** _(time frame: Month 6 up to Month 12)_ — A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1. - **Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12** _(time frame: Month 6 up to Month 12)_ — Remission based on DAS28 + US7: DAS28 \<2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission). ## Secondary Outcomes - **Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12** _(time frame: Month 3, 6, 9 and 12)_ - **Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12** _(time frame: Month 3, 6, 9 and 12)_ - **Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12** _(time frame: Month 3, 6, 9 and 12)_ - **Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12** _(time frame: Month 3, 6, 9 and 12)_ - **Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12** _(time frame: Month 3, 6, 9 and 12)_ - **Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12** _(time frame: Month 6 and 12)_ - **Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12** _(time frame: Month 6 and 12)_ - **Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12** _(time frame: Baseline, Month 6 and Month 12)_ - **Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12** _(time frame: Month 6 and Month 12)_ ## Locations (35) - CHU Dinant Godinne, Yvoir, Namur, Belgium - ASZ Aalst, Aalst, Belgium - Algemeen Stedelijk Ziekenhuis, Aalst, Belgium - Onze Lieve Vrouw Ziekenhuis Aalst, Aalst, Belgium - Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium - St. Lucas ZH, Assebroeck, Belgium - St-Lucas Ziekenhuis, Assebroek, Belgium - Centre Hospitalier Universitarie Brugmann, Brussels, Belgium - CHIREC, Brussels, Belgium - Private Practice, Champion, Belgium - AZ Sint Blasius, Dendermonde, Belgium - AZ Alma, Eeklo, Belgium - Biomedical Research Institute/ Department of Rheumatology, Genk, Belgium - Private Practice Rheumatology, Genk, Belgium - ReumaClinic, Genk, Belgium - Reumatologie Associatie, Genk, Belgium - Private Practice, Genk, Belgium - Universitair Ziekenhuis Gent, Ghent, Belgium - GHdC, Gilly, Belgium - Private Practice, Grand-Manil, Belgium - AZ Groeninge Campus Sint Maarten, Kortrijk, Belgium - CHU Tivoli, La Louvière, Belgium - Centre Hospitalier Universitaire Sart Tilman, Department of Rheumatology, Liège, Belgium - CHU Sart Tilman/ Department of Rheumatology, Liège, Belgium - CHU, Liège, Belgium - Louisastraat 18, Mechelen, Belgium - CHU Ambroise Pare, Mons, Belgium - Hôpital Saintethérèse, Montigny Sur Sambre, Belgium - ISPPC de Charleroi, Montigny-le-Tilleul, Belgium - AZ Damiaan, Ostend, Belgium - Office of Maenaut Kristien, Schoten, Belgium - Sint-Andries Ziekenhuis, Tielt, Belgium - CH Peltzer-Tourelle, Verviers, Belgium - Avenue G Therasse 1, Yvoir, Belgium - 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`locations.office of maenaut kristien|schoten||belgium` — added _(2026-05-12)_ - `locations.sint-andries ziekenhuis|tielt||belgium` — added _(2026-05-12)_ - `locations.ch peltzer-tourelle|verviers||belgium` — added _(2026-05-12)_ - `locations.avenue g therasse 1|yvoir||belgium` — added _(2026-05-12)_ - `locations.cliniques universitaires ucl de mont-godinne|yvoir||belgium` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02202837.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02202837* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*