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Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions (LAPIS-PsA)

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ClinicalTrials.gov Identifier: NCT03106051
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Celgene

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. Proposed duration from first patient in (FPI) to last patient out (LPO) is thus 24 months.

Condition or disease
Arthritis, Psoriatic

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Documentation on the Use of Apremilast in Patients With Psoriatic Arthritis in Practice Conditions
Actual Study Start Date : February 18, 2016
Estimated Primary Completion Date : August 31, 2017
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Group/Cohort
Patients with active psoriatic arthritis
Patients who suffer from active psoriatic arthritis with at least moderate disease corresponding to a PGA of ≥2



Primary Outcome Measures :
  1. 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) [ Time Frame: Up to approximately 7 months ]
    Physician's global assessment (PGA) will be measured on a VAS scale ranging from 0 to 4. Primary endpoint is the percentage of patients with an improvement of minimum 1 point on this VAS scale after about 6 months (visit 3)


Secondary Outcome Measures :
  1. Percentage of patients with an improvement of ≥ 1 points on the Patient Global Assessment (PaGA) scale on visits 1 to 5 compared to baseline [ Time Frame: Up to approximately 54 weeks ]
    Patient Global Assessment will be measured on a VAS scale ranging from 0 to 5. The percentage of patients with an improvement of minimum 1 point will be measured throughout the study.

  2. Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visits 1, 2, 4 and 5 compared to baseline [ Time Frame: Up to approximately 54 weeks ]
    Additionally to the primary endpoint the improvement of the PGA of minimum 1 point will be measured throughout the study.

  3. Efficacy of the treatment with regard to rheumatic changes measured with Tender Joint Count (TJC) on visits 1 to 5 compared to baseline [ Time Frame: Up to approximately 54 weeks ]
    Tender Joint Count will be measured throughout the study and compared to baseline.

  4. Efficacy of the treatment with regard to rheumatic changes measured with Swollen Joint Count (SJC) on visits 1 to 5 compared to baseline [ Time Frame: Up to approximately 54 weeks ]
    Swollen Joint Count will be measured throughout the study and compared to baseline.

  5. Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 5 compared to baseline-Pain [ Time Frame: Up to approximately 54 weeks ]
    Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their pain (0 = no pain, 100 = worst imaginable pain)

  6. Psoriatic arthritis Impact of Disease (PsAID) questionnaire on visits 1, 2 and 5 compared to baseline [ Time Frame: Up to approximately 54 weeks ]
    Improvement of the Impact of Disease (PsAID) will be measured during visit 1, 2 and 5 and compared to baseline

  7. Hannover Functional Ability Questionnaire (FFbH) on visits 1, 2 and 5 compared to baseline [ Time Frame: Up to approximately 54 weeks ]
    Composite score to measure functional improvement will be measured during visits 1, 2 and 5 and compared to baseline

  8. Patient Preference Questionnaire (PPQ) on visit 3 and 5 [ Time Frame: Up to approximately 54 weeks ]
    The therapy preference of the patient will be measured compared to his previous systemic therapy

  9. Assessment of psoriatic skin changes (Body Surface Area, BSA) on visits 1 to 5 [ Time Frame: Up to approximately 54 weeks ]
    Extension of the psoriatic plaques will be measured by body surface area (BSA) throughout the study

  10. Adverse Events (AEs) [ Time Frame: Up to approximately 54 weeks ]
    Number of subjects with adverse events

  11. Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 5 compared to baseline- Enthesitis [ Time Frame: Up to approximately 54 weeks ]
    Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their enthesitis (0 = no enthesitis, 100 = worst imaginable enthesitis)

  12. Efficacy of the treatment with regard to rheumatic changes measured with Visual Analog Scale (VAS) on visits 1 to 5 compared to baseline- Joints [ Time Frame: Up to approximately 54 weeks ]
    Visual Analog Scale; scale from 0-100 to question how the patient feels subjectively about their joints (0 = no affected joints, 100 = heavily affected joints)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106051


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Germany
Rheumatology at Struenseehaus Recruiting
Hamburg-Altona, Hamburg, Germany, 22767
Klinikum Stephansplatz Recruiting
Hamburg, Germany, 20354
Sponsors and Collaborators
Celgene
Investigators
Study Director: Markus Altmann, MD Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03106051     History of Changes
Other Study ID Numbers: CC-10004-PSA-008
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: April 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Arthritis
Psoriatic
Observational
Apremilast

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents