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Trial record 7 of 9 for:    Orencia | psoriasis

Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants (ALTEA)

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ClinicalTrials.gov Identifier: NCT03419143
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.

Condition or disease Intervention/treatment
Psoriatic Arthritis (PsA) Other: Non-interventional

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Biologic-naive adults initiating abatacept for PsA
Adult patients, naïve of abatacept and any other biologic agent, initiating abatacept for PsA, under usual practice conditions
Other: Non-interventional
Non-interventional

Adults initiating abatacept for PsA after one failed TNFi
Adult patients, naïve of abatacept, who previously failed one tumor necrosis factor inhibitor (TNFi), initiating abatacept for PsA, under usual practice conditions
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  1. Disease Activity index for PSoriatic Arthritis (DAPSA) [ Time Frame: 12 months ]
    Disease Activity index for PSoriatic Arthritis (DAPSA) equals number of tender joints (0-68) plus number of swollen joints (0-66) plus C-reactive protein (mg/dl) plus participant's disease activity level (0 not active-10 very active) plus participant's joint pain level (0 no pain-10 very severe)


Secondary Outcome Measures :
  1. Number of adverse events per participants [ Time Frame: 12 months ]
  2. Skin involvement under abatacept therapy as assessed by Psoriasis Area and Severity Index (PASI) [ Time Frame: 12 months ]
    The PASI score consists of 4 items that are assessed (surface area, severity of erythema [redness], induration [thickness], and desquamation [scale]), evaluated for 4 body areas (head, trunk, and upper and lower extremities).

  3. Physician Global Assessment (PGA) [ Time Frame: 12 months ]
  4. Number of reasons for stopping or switching therapy [ Time Frame: 12 months ]
    Including patient/physician treatment satisfaction and compliance

  5. Number of participants using abatacept monotherapy [ Time Frame: 12 months ]
  6. Retention rate of abatacept [ Time Frame: 12 months ]
    Retention rate over the 12-month observation period calculated as the proportion of patients continuing with abatacept treatment at 12 months

  7. Number of serious adverse events per participants [ Time Frame: 12 months ]
  8. Number of participants using abatacept combination therapy [ Time Frame: 12 months ]
  9. Participant's quality of life as assessed by the Eular Psoriatic Arthritis Impact of Disease; PSAID12 For Clinical Practice [ Time Frame: 12 months ]
  10. Distribution of socio-demographic characteristics in PsA patients at abatacept therapy initiation using descriptive statistics [ Time Frame: Baseline ]
  11. Distribution of medical history in PsA patients at abatacept therapy initiation using descriptive statistics [ Time Frame: Baseline ]
  12. Distribution of disease history in PsA patients at abatacept therapy initiation using descriptive statistics [ Time Frame: Baseline ]
  13. Distribution of comorbidities in PsA patients at abatacept therapy initiation using descriptive statistics [ Time Frame: Baseline ]
  14. Distribution of clinical measures in PsA patients at abatacept therapy initiation using descriptive statistics [ Time Frame: Baseline ]
  15. Skin involvement under abatacept therapy as assessed by body surface area (BSA) [ Time Frame: 12 months ]
    BSA considers the surface area of the patient's handprint (palm and fingers) as representing 1% of the body's surface area that is affected. The BSA is also assessed by the phycisian.



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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
The patient population targeted by the study consists of patients with PsA that initiate treatment with abatacept
Criteria

Inclusion Criteria:

  • Patients 18 years of age at enrollment
  • Patients who signed an informed consent
  • Patients diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group17
  • Patients naïve of abatacept and who at their physician's discretion initiate abatacept
  • Patients meeting criteria for abatacept treatment for PsA as specified in the German label

Exclusion Criteria:

  • Patients who are currently included in any interventional clinical trial in PsA/RA

Other protocol defined criteria inclusion/exclusion criteria could apply


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): NCT03419143


Contacts
Contact: Recruiting sites have contact information. Please contact the sites. directly. If there is no contact information please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

Locations
Germany
Local Institution Recruiting
Nurnberg, Germany, 90429
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03419143     History of Changes
Other Study ID Numbers: IM101-675
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: February 2018

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

Additional relevant MeSH terms:
Psoriasis
Abatacept
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents