Prospective Evaluation of the Radiographic Efficacy of Enbrel

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01623752
• Date of registration: 18/06/2012
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Prospective Evaluation of the Radiographic Efficacy of Enbrel PRERA
• Scientific title: A PROSPECTIVE EVALUATION OF THE RADIOGRAPHIC EFFICACY OF ETANERCEPT IN PATIENTS WITH RHEUMATOID ARTHRITIS OR PSORIATIC ARTHRITIS.
• Date of first enrolment: February 2012
• Target sample size: 1821
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01623752
• Study type: Observational

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Psoriasis Arthritis

Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

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

Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): CAS [Time Frame: Pre-treatment, Week 78]

Change From Pre-treatment in Normalized Radiographic Progression of mTSS or Adapted mTSS at End of Phase 1 (Week 78): EAS [Time Frame: 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 [Time Frame: 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 [Time Frame: Pre-treatment, Week 156]

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) [Time Frame: Baseline, Week 78]

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

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) [Time Frame: Baseline, Week 78]

Secondary Outcome(s)

Change From Baseline in Disease Activity Score-28 (DAS-28) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 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) [Time Frame: Baseline up to Week 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 [Time Frame: 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 [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156]

Linear Relationship Between Normalized Radiographic Progression and Disease Duration [Time Frame: Baseline up to Week 78]

Change From Baseline in Total Joint Space Narrow Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) [Time Frame: Baseline, Week 78, 156]

Effect on Normalized Radiographic Progression With Respect to Baseline Positivity of Anti-citrullinated Protein Antibody (ACPA) - Rheumatoid Factor (RF) [Time Frame: Baseline up to Week 78]

Effect on Normalized Radiographic Progression With Respect to Baseline Disease Activity Score-28 (DAS-28) [Time Frame: Baseline up to Week 78]

Effect on Normalized Radiographic Progression With Respect to Previous Treatment With Biologics [Time Frame: Baseline up to Week 78]

Percentage of Participants With Rheumatoid Arthritis, With Low Disease Activity Based on Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) [Time Frame: 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 [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156]

Change From Baseline in Hannover Functional Ability Questionnaire (FFbH) at Week 13, 26, 39, 52, 65, 78, 104, 130 and 156 [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156]

Change From Baseline in Total Erosion Score at End of Phase 1 (Week 78) and Phase 2 (Week 156) [Time Frame: Baseline, Week 78, 156]

Duration of Morning Stiffness in Participants With Temporary Rigidity [Time Frame: 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) [Time Frame: Baseline, Week 78, 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156]

Effect on Normalized Radiographic Progression With Respect to Baseline Usage of Concomitant Medication [Time Frame: Baseline up to Week 78]

Number of Participants Categorized in Different Classes Depending Upon Percentage of Body Surface Area (BSA) Affected by Psoriatic Arthritis [Time Frame: 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) [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156]

Relationship Between Rheuma Unterstutzungsdienst (RUDI) and Psoriasis Informationsteam (PIT) Participation and Continuation of Treatment With Etanercept [Time Frame: Baseline up to Week 156]

Number of Participants in Each Level of the 5 Dimensions of Health Questionnaire by the EuroQol Group (EQ-5D) [Time Frame: Baseline, Week 13, 26, 39, 52, 65, 78, 104, 130, 156]

Secondary ID(s)

B1801317

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01623752