Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

NCT02202837 | Completed Results

• 2 other identifiers: B1801378REACH-RA
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 35

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (7)

• 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

  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.

  Month 6 up to Month 12

• Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till 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.

  Month 6 up to Month 12

• Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till 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.

  Month 6 up to Month 12

• 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

  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).

  Month 6 up to Month 12

• 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

  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).

  Month 6 up to Month 12

• Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till 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.

  Month 6 up to Month 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 Maintained Till 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).

  Month 6 up to Month 12

Secondary Outcomes (15)

• Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

• Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12

  Month 3, 6, 9 and 12

• Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12

  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

  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

  Month 3, 6, 9 and 12

Study Arms (2)

Etanercept First

Adult patients with RA who receive etanercept as first biologic, according to prevailing Belgian reimbursement criteria

Drug: etanercept

Etanercept second

Adult patients who receive etanercept as second biologic, according to prevailing Belgian reimbursement criteria

Drug: etanercept

Interventions

etanercept DRUG

etanercept 1 x 50 mg/week or 2 x 25mg/week

Etanercept First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting with moderate-to-severe RA in daily clinical practice

You may qualify if:

• Patients with active RA who start treatment with etanercept according to the prevailing reimbursement criteria and dosing in line with the SmPC.
• First cohort: Etanercept is the first biological product prescribed.
• Second cohort: Etanercept is the second biological product prescribed.
• Capable of understanding and willing to provide signed and dated written, voluntary informed consent before any protocol-specific procedures are performed.
• Eighteen (18) years of age or older at time of consent.

You may not qualify if:

• \. History of or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or to give informed consent.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (35)

CHU Dinant Godinne

Yvoir, Namur, 5530, Belgium

Location

ASZ Aalst

Aalst, 9300, Belgium

Location

Algemeen Stedelijk Ziekenhuis

Aalst, B-9300, Belgium

Location

Onze Lieve Vrouw Ziekenhuis Aalst

Aalst, B-9300, Belgium

Location

Onze Lieve Vrouw Ziekenhuis

Aalst, B-9300, Belgium

Location

St. Lucas ZH

Assebroeck, 8310, Belgium

Location

St-Lucas Ziekenhuis

Assebroek, B-8310, Belgium

Location

Centre Hospitalier Universitarie Brugmann

Brussels, 1020, Belgium

Location

CHIREC

Brussels, 1040, Belgium

Location

Private Practice

Champion, B-5020, Belgium

Location

AZ Sint Blasius

Dendermonde, 9200, Belgium

Location

AZ Alma

Eeklo, 9900, Belgium

Location

Biomedical Research Institute/ Department of Rheumatology

Genk, 3600, Belgium

Location

Private Practice Rheumatology

Genk, 3600, Belgium

Location

ReumaClinic

Genk, 3600, Belgium

Location

Reumatologie Associatie

Genk, 3600, Belgium

Location

Private Practice

Genk, B-3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

GHdC

Gilly, B-6060, Belgium

Location

Private Practice

Grand-Manil, 5030, Belgium

Location

AZ Groeninge Campus Sint Maarten

Kortrijk, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

Centre Hospitalier Universitaire Sart Tilman, Department of Rheumatology

Liège, 4000, Belgium

Location

CHU Sart Tilman/ Department of Rheumatology

Liège, 4000, Belgium

Location

CHU

Liège, Belgium

Location

Louisastraat 18

Mechelen, 2800, Belgium

Location

CHU Ambroise Pare

Mons, B-7000, Belgium

Location

Hôpital Saintethérèse

Montigny Sur Sambre, 6061, Belgium

Location

ISPPC de Charleroi

Montigny-le-Tilleul, 6110, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

Office of Maenaut Kristien

Schoten, B-2900, Belgium

Location

Sint-Andries Ziekenhuis

Tielt, B-8700, Belgium

Location

CH Peltzer-Tourelle

Verviers, B-4800, Belgium

Location

Avenue G Therasse 1

Yvoir, 5530, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, 5530, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 29, 2014
• Study Start: August 12, 2014
• Primary Completion: April 24, 2017
• Study Completion: April 24, 2017
• Last Updated: December 3, 2018
• Results First Posted: December 3, 2018

Record last verified: 2018-04

Locations

BE (35)