Clinical trial NCT03106051: Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions
Official title: Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Psoriatic
Keywords: Arthritis
Psoriatic
Observational
Apremilast
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2017-04-10
Enrollment: 526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overall approx. 500 patients with active psoriatic arthritis are to be enrolled. Inclusion and exclusion criteria derive from the current Otezla® summary of product characteristics and the criteria.

Brief summary: A total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-


Eligibility criteria: Inclusion Criteria:

* The decision to treat with Otezla® has been made independently before inclusion in this study
* Patient age ≥ 18 years
* Existing diagnosis of active psoriatic arthritis
* At least moderately severe psoriatic arthritis (Physician's Global Assessment (PGA) scale ≥ 2)
* Insufficient response or intolerance to previous Disease-Modifying Anti-Rheumatic Drug (DMARD) treatment (disease modifying anti-rheumatic drugs)
* A written informed consent statement by the patient permitting data collection, evaluation, storage and transfer

Exclusion Criteria:

* Pregnancy
* Hypersensitivity to apremilast or one of the other ingredients in the film tablets
* Other criteria according to the summary of product characteristics Breast-feeding

Primary outcomes:
measure: Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4)
timeFrame: Up to approximately 7 months
Secondary outcomes:
measure: Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 7 compared to baseline
timeFrame: Up to approximately 104 weeks
measure: Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visits 1, 2, 4, 5, 6, 7 compared to baseline
timeFrame: Up to approximately 104 weeks
measure: Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 7 compared to baseline
timeFrame: Up to approximately 104 weeks
measure: Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 7 compared to baseline
timeFrame: Up to approximately 104 weeks
measure: Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Pain
timeFrame: Up to approximately 104 weeks
measure: Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2, 3, 5 and 7 compared to baseline
timeFrame: Up to approximately 104 weeks
measure: Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2, 3, 5 and 7 compared to baseline
timeFrame: Up to approximately 104 weeks
measure: Patient Preference Questionnaire (PPQ) on visits 3, 5 and 7
timeFrame: Up to approximately 104 weeks
measure: Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 7
timeFrame: Up to approximately 104 weeks
measure: Adverse Events (AEs)
timeFrame: Up to approximately 104 weeks
measure: Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Enthesitis
timeFrame: Up to approximately 104 weeks
measure: Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 7 compared to baseline- Joints
timeFrame: Up to approximately 104 weeks
Other outcomes:
Locations:
city: Hamburg-Altona
country: Germany
facility: Rheumatology at Struenseehaus
state: Hamburg
city: Hamburg
country: Germany
facility: Klinikum Stephansplatz
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: