Rheumatoid ArthritisASCENDNCT03457792
A Study of Abatacept in Participants That Only Recently Started to Develop Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 158 participants
- Where
- 1 siteGermany
- Study dates
- 17 Apr 2018to 30 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 participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.
Who may be able to join
- Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
- Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)
Who cannot join
- Participants who are currently included in any interventional clinical trial in RA
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
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 |
|---|---|---|
| Abatacept for Rheumatoid Arthritis (RA) | Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients continuing with abatacept treatment
Measured: Up to 12 months
Secondary outcomes (25)
Anti-citrullinated protein antibody (ACPA) titer
Measured: At baseline
Concomitant treatment given with abatacept as determined by the investigator
Measured: Up to 12 months
Dosage of abatacept as determined by the investigator
Measured: Up to 12 months
Frequency of administration of abatacept
Measured: Up to 12 months
Reason for abatacept treatment initiation as determined by the investigator
Measured: At baseline
Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)
Measured: Up to 12 months
Socio-demographics of participants as determined by the investigator
Measured: At baseline
Disease history of participants as determined by the investigator
Measured: At baseline
Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)
Measured: Up to 12 months
Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)
Measured: Up to 12 months
Simplified Disease Activity Score (based on 28 joints) (DAS28)
DAS28: Swollen joint count [SJC], tender joint count [TJC], C-reactive protein [CRP], erythrocyte sedimentation rate [ESR]
Measured: Up to 12 months
Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria
Measured: Up to 12 months
Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)
Measured: Up to 12 months
Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2
Measured: Up to 12 months
Number of patients who achieve the first remission state, DAS28 < 2.6
Measured: Up to 12 months
Number of Adverse Events (AE)
Measured: Up to 12 months
Number of Serious Adverse Events (SAE)
Measured: Up to 12 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: Up to 12 months
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
Measured: At baseline
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
Measured: Up to 12 months
Rheumatoid factor (RF)
Measured: Up to 12 months
Patient global assessment (PGA)
Measured: Up to 12 months
Evaluator global assessment (EGA)
Measured: Up to 12 months
Clinical disease activity index (CDAI)
Measured: Up to 12 months
Simple disease activity index (SDAI)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start17 Apr 2018
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- 158 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
- NCT03457792
- Sponsor's protocol ID
- IM101-679
- Acronym
- ASCEND
- Status last verified
- Jun 2022
- First submitted
- 13 Feb 2018
- Last updated
- 14 Jun 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 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abatacept in Early-Stage Rheumatoid Arthritis Patients: Longterm Experience and Efficacy in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03457792
- Acronym / sponsor ID
- ASCEND / IM101-679
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 8 Mar 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.
This is a long-term study of Abatacept in participants that only recently started to develop Rheumatoid Arthritis, a chronic inflammatory disorder affecting mainly joints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abatacept for Rheumatoid Arthritis (RA) | – | –Participants diagnosed with moderate to severe active RA within the last 24 months and initiated treatment with Abatacept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participant population targeted in this study consists of participants with early-stage RA (i.e. diagnosis of RA not longer than 24 months) that initiate treatment with Abatacept.
Key inclusion criteria (2 listed)
- Participants recently (within the last 24 months before enrollment) diagnosed with established moderate to severe active RA
- Participants naïve of abatacept and who, at their physician's discretion, are initiated with abatacept according the German label/SmPC (Summary of product characteristics)
Key exclusion criteria (2 listed)
- Participants who are currently included in any interventional clinical trial in RA
- Other protocol defined inclusion/exclusion criteria could apply
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
Number of patients continuing with abatacept treatment
Time frame: Up to 12 months
25 secondary outcomes
Anti-citrullinated protein antibody (ACPA) titer
Time frame: At baseline
Concomitant treatment given with abatacept as determined by the investigator
Time frame: Up to 12 months
Dosage of abatacept as determined by the investigator
Time frame: Up to 12 months
Frequency of administration of abatacept
Time frame: Up to 12 months
Reason for abatacept treatment initiation as determined by the investigator
Time frame: At baseline
Number of patients previously receiving disease modifying anti-rheumatic drug (DMARD)
Time frame: Up to 12 months
Socio-demographics of participants as determined by the investigator
Time frame: At baseline
Disease history of participants as determined by the investigator
Time frame: At baseline
Number of patients with cardiovascular risk factors (smoker, hypertension, diabetes, dyslipidemia)
Time frame: Up to 12 months
Number of patients with other pathologies (cardiovascular, respiratory, liver, renal, cancer, infections, and immuno-deficiency)
Time frame: Up to 12 months
Simplified Disease Activity Score (based on 28 joints) (DAS28)
Time frame: Up to 12 months
Number of patients who achieve the first response to treatment per European League Against Rheumatism (EULAR) response criteria
Time frame: Up to 12 months
Number of patients who achieve the first clinically significant Disease Activity Score (DAS)-change (≥ 1.2)
Time frame: Up to 12 months
Number of patients who achieve the first low disease activity score (LDAS), DAS28 ≤ 3.2
Time frame: Up to 12 months
Number of patients who achieve the first remission state, DAS28 < 2.6
Time frame: Up to 12 months
Number of Adverse Events (AE)
Time frame: Up to 12 months
Number of Serious Adverse Events (SAE)
Time frame: Up to 12 months
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Up to 12 months
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
Time frame: At baseline
Existence or the absence of radiographic erosions as determined by the investigator by imaging technique
Time frame: Up to 12 months
Rheumatoid factor (RF)
Time frame: Up to 12 months
Patient global assessment (PGA)
Time frame: Up to 12 months
Evaluator global assessment (EGA)
Time frame: Up to 12 months
Clinical disease activity index (CDAI)
Time frame: Up to 12 months
Simple disease activity index (SDAI)
Time frame: Up to 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 14 Jun 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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 Rheumatoid Arthritis, 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 2 inclusion and 2 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 14 Jun 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?
Number of patients continuing with abatacept treatment (time frame: Up to 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 14 Jun 2022.