A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02486302
• Date of registration: 28/06/2015
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Study To Evaluate The Efficacy Of Enbrel (REGISTERED) Etanercept Over A Period Of 12 Months In The Routine Treatment Of Patients With Rheumatoid Arthritis, Axial Spondyloarthritis, Psoriatic Arthritis, Or Plaque Psoriasis. ADEQUATE
• Scientific title: A PROSPECTIVE, MULTICENTER NON-INTERVENTIONAL STUDY TO EVALUATE THE EFFICACY OF ENBREL (REGISTERED) (ETANERCEPT) OVER A PERIOD OF 12 MONTHS IN THE ROUTINE TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS, AXIAL SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, OR PLAQUE PSORIASIS WITH PARTICULAR FOCUS ON THE CLINICAL STATUS IMPROVEMENTS STILL OBSERVABLE AFTER 12 WEEKS OF TREATMENT
• Date of first enrolment: March 24, 2015
• Target sample size: 1534
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02486302
• Study type: Observational

Countries of recruitment

Germany

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of RA, axSpA, PsA or PsO

- No prior treatment with etanercept and eligibility for treatment with etanercept
according to the summary of product characteristics.

Exclusion Criteria:

- The contraindications, special warnings, and precautions according to the summary of
product characteristics for etanercept shall apply.

- The additional documentation of the patient in another post-marketing study with
etanercept is not permitted.



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

Health Condition(s) or Problem(s) studied

Plaque Psoriasis

Rheumatoid Arthritis

Axial Spondyloarthritis

Psoriatic Arthritis

Intervention(s)

Drug: Etanercept

Primary Outcome(s)

Number of Participants With PsO Who Achieved 75% Improvement From Baseline in Psoriasis Area & Severity Index(PASI75) Score or Physician's Global Assessment(PGA) of Clear or Almost Clear And Dermatology Life Quality Index(DLQI) Total Score of 0 or 1 [Time Frame: Week 12]

Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 and Maintained Till 52 Weeks [Time Frame: Week 24 up to Week 52]

Number of Participants With Axial Spondyloarthritis (axSpA) Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 12 [Time Frame: Week 12]

Number of Participants With Psoriatic Arthritis (PsA) Who Achieved Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 12 [Time Frame: Week 12]

Number of Participants With Plaque Psoriasis (PsO) Who Achieved 75% Improvement in Psoriasis Area and Severity Index (PASI75) Score or a Physician's Global Assessment (PGA) of "Clear" or "Almost Clear" and DLQI Total Score of 0 or 1 at Week 24 [Time Frame: Week 24]

Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 [Time Frame: Week 12]

Number of Participants With Axial Spondyloarthritis (axSpA) Achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) Less Than (<) 1.3 at Week 24 [Time Frame: Week 24]

Number of Participants With Psoriatic Arthritis (PsA) Achieving Either 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 or Met Minimal Disease Activity (MDA) Criteria at Week 24 [Time Frame: Week 24]

Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 12 and Maintained Till 52 Weeks [Time Frame: Week 12 up to Week 52]

Number of Participants With Rheumatoid Arthritis (RA) Who Achieved 28 Joint Disease Activity Score (DAS28) Less Than (<) 2.6 at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Percentage of Participants Who Discontinued Treatment Due to Lack of Efficacy or Adverse Events [Time Frame: Baseline up to Week 52]

Mean Visual Analogue Scale (VAS) Pain Scores at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Patient Health Quessionare-2 (PHQ-2) Scores at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Psoriatic Arthritis(PsA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Ankylosing Spondylitis(axSpA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Ankylosing Spondylitis (axSpA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Mean Percentage of Total Body Surface Area (BSA) for Participants With Plaque Psoriasis (PsO) and Psoriasis Arthritis (PsA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Clinical Disease Activity Index (CDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Mean Visual Analogue Scale (VAS) Fatigue Scores at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Median Time to Achieve Psoriasis Area and Severity Index 75 (PASI 75) Response in Participants With Plaque Psoriasis (PsO) [Time Frame: Baseline up to Week 24]

Dermatology Life Quality Index (DLQI) Total Score for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Hannover Functional Questionnaire (FFbH) Functional Capacity Score of Participants With Rheumatoid Arthritis (RA), Axial Spondyloarthritis (axSpA), Psoriasis Arthritis (PsA) at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Occiput-to-wall Distance of Participants With Axial Spondyloarthritis (axSpA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Physician Global Assessment (PGA) of Disease Activity Scores at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Patient Global Assessment of Disease Activity (PtGA) Scores at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Change From Baseline in Psoriasis Area and Severity Index (PASI) in Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [Time Frame: Baseline, Weeks 12, 24, 36, 52]

Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Treated Set (TS) [Time Frame: Baseline up to Weeks 12, 24, 36, 52]

Psoriatic Arthritis (PsA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Number of Participants With Treatment Emergent Adverse Events up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [Time Frame: Baseline up to Weeks 12, 24, 36, 52]

Patient Assessment of Pruritus for Participants With Plaque Psoriasis (PsO) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Mean of Total Number of Affected Fingers or Toes by Dactylitis in Participants With Psoriatic Arthritis (PsA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Percentage of Participants Who Continued With Treatment up to Weeks 12, 24, 36 and 52: Per-Protocol (PP) Set [Time Frame: Baseline up to Weeks 12, 24, 36, 52]

Psoriasis Area and Severity Index (PASI) Body Segment Scores in Participants With Plaque Psoriasis (PsO) [Time Frame: Weeks 12, 24, 36, 52]

Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Hannover Functional Questionnaire (FFbH) and Morning Stiffness at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Number of Participants Achieving 28 Joint Disease Activity Score (DAS28) Remission at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Plaque Psoriasis (PsO): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Number of Participants Who Switched to Other Therapy After Treatment Discontinuation [Time Frame: Baseline up to Week 52]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to Weeks 12, 24, 36 and 52: Treated Set [Time Frame: Baseline up to Weeks 12, 24, 36, 52]

Psoriasis Area and Severity Index (PASI) Component Scores in Participants With Plaque Psoriasis (PsO) [Time Frame: Weeks 12, 24, 36, 52]

Rheumatoid Arthritis(RA): Spearman Correlation Coefficient Between Patient Global Assessment (PtGA) of Disease Activity, VAS Fatigue, VAS Pain Score, Patient Health Quessionare-2 (PHQ-2) and PGA of Disease Activity at Weeks 12, 24, 36, 52 [Time Frame: Weeks 12, 24, 36, 52]

Simplified Disease Activity Index (SDAI) Scores of Participants With Rheumatoid Arthritis (RA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Number of Affected Enthesis in Participants With Axial Spondyloarthritis (axSpA) and Psoriatic Arthritis(PsA) at Weeks 12, 24, 36 and 52 [Time Frame: Weeks 12, 24, 36, 52]

Secondary ID(s)

ADEQUATE

B1801385

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/06/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02486302