Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03419143
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : August 15, 2019
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

Layout table for study information
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 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
Cohort 1
naïve of abatacept, other biologic agents and Targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs)
Other: Non-interventional
Non-interventional

Cohort 2
"naïve of abatacept, who previously failed one tumor necrosis factor inhibitor (TNFi), but are naïve of any other biologic agent and tsDMARDs"
Other: Non-interventional
Non-interventional

Cohort 3
naïve of abatacept, who previously failed treatment with tsDMARDs and/or biologic agents** other than a single TNFi
Other: Non-interventional
Non-interventional




Primary Outcome Measures :
  1. Disease Activity index for PSoriatic Arthritis (DAPSA) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Participant retention rate [ Time Frame: 12 Months ]
  2. Proportion of concomitant treatment given [ Time Frame: 12 Months ]
  3. Initial dosage of Abatacept given [ Time Frame: At Treatment Initiation ]
  4. Frequency of Abatacept administration [ Time Frame: 12 months ]
  5. Descriptive Analysis: Reasons for Abatacept initiation [ Time Frame: up to 2 years prior to treatment ]
  6. Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD) [ Time Frame: up to 2 years prior to treatment ]
  7. Descriptive Analysis: Socio-Demographics at Treatment Initiation [ Time Frame: At Treatment Initiation ]
  8. Descriptive Analysis: Disease history at Treatment initiation [ Time Frame: Prior to treatment ]
  9. Incidence of Risk factors and Comorbidities [ Time Frame: At Treatment Initiation ]
  10. Descriptive Analysis: Baseline Characteristics [ Time Frame: up to 2 years prior to treatment ]
  11. Descriptive Analysis: Change in participant characteristics and symptoms [ Time Frame: 12 months ]
  12. Proportion of Rheumatologist: Geography [ Time Frame: up to 2 months prior to treatment to 12 months post treatment ]
  13. Proportion of Rheumatologist: Type of Institution [ Time Frame: up to 2 months prior to treatment to 12 months post treatment ]
  14. Proportion and type of treatment after abatacept discontinuation [ Time Frame: 12 months ]
  15. Proportion of reasons for abatacept discontinuation and initiation of new therapy [ Time Frame: 12 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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/Rheumatoid Arthritis (RA)

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
Layout table for location 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
Layout table for location information
Germany
Local Institution Recruiting
Nurnberg, Germany, 90429
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03419143    
Other Study ID Numbers: IM101-675
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases