Psoriatic Arthritis (PsA)ALTEANCT03419143
Safety and Effectiveness of Abatacept in Psoriatic Arthritis Participants
An observational study of Psoriatic Arthritis (PsA), run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis (PsA)
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- 2 Mar 2018to 31 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population targeted by the study consists of patients with PsA that initiate treatment with abatacept
Who may be able to join
- Participants 18 years or older
- Participants who signed an informed consent
- Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18
- Participants naïve of abatacept and who at their physician's discretion initiate abatacept
- Participants meeting criteria for abatacept treatment for PsA as specified in the German label
Who cannot join
- Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)
The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.
- Conditions
- Psoriatic Arthritis (PsA)
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity index for PSoriatic Arthritis (DAPSA)
Measured: 12 months
Secondary outcomes (15)
Participant retention rate
Measured: 12 Months
Proportion of concomitant treatment given
Measured: 12 Months
Initial dosage of Abatacept given
Measured: At Treatment Initiation
Frequency of Abatacept administration
Measured: 12 months
Descriptive Analysis: Reasons for Abatacept initiation
Measured: up to 2 years prior to treatment
Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD)
Measured: up to 2 years prior to treatment
Descriptive Analysis: Socio-Demographics at Treatment Initiation
Measured: At Treatment Initiation
Descriptive Analysis: Disease history at Treatment initiation
Measured: Prior to treatment
Incidence of Risk factors and Comorbidities
Measured: At Treatment Initiation
Descriptive Analysis: Baseline Characteristics
Measured: up to 2 years prior to treatment
Descriptive Analysis: Change in participant characteristics and symptoms
Measured: 12 months
Proportion of Rheumatologist: Geography
Measured: up to 2 months prior to treatment to 12 months post treatment
Proportion of Rheumatologist: Type of Institution
Measured: up to 2 months prior to treatment to 12 months post treatment
Proportion and type of treatment after abatacept discontinuation
Measured: 12 months
Proportion of reasons for abatacept discontinuation and initiation of new therapy
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start2 Mar 2018
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic Arthritis (PsA)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419143
- Sponsor's protocol ID
- IM101-675
- Acronym
- ALTEA
- Status last verified
- May 2022
- First submitted
- 24 Jan 2018
- Last updated
- 31 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept - Long-Term Real-Life Experience in Psoriatic Arthritis (PsA) in Germany: an Observational Study (ALTEA)
- ClinicalTrials.gov ID
- NCT03419143
- Acronym / sponsor ID
- ALTEA / IM101-675
- Conditions
- Psoriatic Arthritis (PsA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is a long-term, observational study of Abatacept in patients with Psoriatic Arthritis, a chronic inflammatory disorder.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population targeted by the study consists of patients with PsA that initiate treatment with abatacept
Key inclusion criteria (5 listed)
- Participants 18 years or older
- Participants who signed an informed consent
- Participants diagnosed with PsA as per the criteria of the Classification of Psoriatic Arthritis (CASPAR) Study Group18
- Participants naïve of abatacept and who at their physician's discretion initiate abatacept
- Participants meeting criteria for abatacept treatment for PsA as specified in the German label
Key exclusion criteria (1 listed)
- Participants who are currently included in any interventional clinical trial in PsA/Rheumatoid Arthritis (RA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Disease Activity index for PSoriatic Arthritis (DAPSA)
Time frame: 12 months
15 secondary outcomes
Participant retention rate
Time frame: 12 Months
Proportion of concomitant treatment given
Time frame: 12 Months
Initial dosage of Abatacept given
Time frame: At Treatment Initiation
Frequency of Abatacept administration
Time frame: 12 months
Descriptive Analysis: Reasons for Abatacept initiation
Time frame: up to 2 years prior to treatment
Proportion of patients previously receiving by type of Disease modifying anti-rheumatic drug (DMARD)
Time frame: up to 2 years prior to treatment
Descriptive Analysis: Socio-Demographics at Treatment Initiation
Time frame: At Treatment Initiation
Descriptive Analysis: Disease history at Treatment initiation
Time frame: Prior to treatment
Incidence of Risk factors and Comorbidities
Time frame: At Treatment Initiation
Descriptive Analysis: Baseline Characteristics
Time frame: up to 2 years prior to treatment
Descriptive Analysis: Change in participant characteristics and symptoms
Time frame: 12 months
Proportion of Rheumatologist: Geography
Time frame: up to 2 months prior to treatment to 12 months post treatment
Proportion of Rheumatologist: Type of Institution
Time frame: up to 2 months prior to treatment to 12 months post treatment
Proportion and type of treatment after abatacept discontinuation
Time frame: 12 months
Proportion of reasons for abatacept discontinuation and initiation of new therapy
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis (PsA), run by Bristol-Myers Squibb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity index for PSoriatic Arthritis (DAPSA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.