Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03419143
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bristol-Myers Squibb
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bristol-Myers Squibb
Principal Investigator Affiliation Bristol-Myers Squibb
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriatic Arthritis (PsA)
Study Website: View Trial Website
Arms & Interventions

Arms

: Cohort 1

naïve of abatacept, other biologic agents and Targeted synthetic disease modifying anti-rheumatic drugs (tsDMARDs)

: Cohort 2

"naïve of abatacept, who previously failed one tumor necrosis factor inhibitor (TNFi), but are naïve of any other biologic agent and tsDMARDs"

: Cohort 3

naïve of abatacept, who previously failed treatment with tsDMARDs and/or biologic agents** other than a single TNFi

Interventions

Other: - Non-interventional

Non-interventional

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Local Institution, Nurnberg, Germany

Status

Recruiting

Address

Local Institution

Nurnberg, , 90429

Site Contact

Site 0001

Clinical.Trials@bms.com

please email

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