Prospective Evaluation of the Radiographic Efficacy of Enbrel

NCT01623752 | Completed Results

• 1 other identifier: B1801317
• Study Type: observational
• Target: 1,821
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Rheumatoid Arthritis; Psoriasis Arthritis

Outcome Measures

Primary Outcomes (8)

• 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)

  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.

  Baseline, Week 78

• 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)

  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.

  Baseline, Week 78

• Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at the End of Phase 2 (Week 156): EAS

  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.

  Baseline, Week 156

• Change From Baseline in Van Der Heijde Total Modified Total Sharp Score or Adapted mTSS at End of Phase 2 (Week 156): CAS

  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.

  Baseline, Week 156

• Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS

  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.

  Pre-treatment, Week 78

• Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS

  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.

  Pre-treatment, Week 78

• Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 2 (Week 156): EAS

  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.

  Pre-treatment, Week 156

• Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at the End of Phase 2 (Week 156): CAS

  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.

  Pre-treatment, Week 156

Secondary Outcomes (24)

• Linear Relationship Between Normalized Radiographic Progression and Disease Duration

  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 Usage of Concomitant Medication

  Baseline up to Week 78

• Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics

  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

Other Outcomes (7)

• Number of Participants With Treatment-Emergent Adverse Events (AEs) and Treatment-Emergent Serious Adverse Events (SAEs)

  Baseline up to Week 156

• Number of Participants With Treatment Emergent Adverse Events (AEs) by Severity

  Baseline up to Week 156

• Number of Participants With Discontinuation of Etanercept Treatment

  Week 78, 156

Study Arms (2)

Patients with Rheumatoid Arthritis

Drug: Etanercept

Patients with Psoriasis Arthritis

Drug: Etanercept

Interventions

Etanercept DRUG

The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.

Also known as: Enbrel

Patients with Rheumatoid Arthritis

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

Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Rheumatoid Arthritis or Psoriasis Arthritis

You may qualify if:

• 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.
• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Publications (1)

• Wassenberg S, Rau R, Klopsch T, Plenske A, Jobst J, Klaus P, Meng T, Loschmann PA. Etanercept is Effective and Halts Radiographic Progression in Rheumatoid Arthritis and Psoriatic Arthritis: Final Results from a German Non-interventional Study (PRERA). Rheumatol Ther. 2023 Feb;10(1):117-133. doi: 10.1007/s40744-022-00491-4. Epub 2022 Oct 17.

  PMID: 36251174 DERIVED

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: June 18, 2012
• First Posted: June 20, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 16, 2019
• Results First Posted: August 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share