Rheumatoid ArthritisNCT01137851
Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 3,940 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Sep 2010
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Commercial health plan members
Who may be able to join
- 18 to 64 years of age at index date
- Diagnosis of RA during the study period (ICD-9CM 714.xx)
- Evidence of at least one biologic DMARD of interest during the study timeframe
- Continuous enrollment during the study timeframe
- Both medical and pharmacy benefits
- No evidence of a claim for a bDMARD in the 6-month pre-period
Who cannot join
- Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe
About this study
Official title: Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies
The purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)
- 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 |
|---|---|---|
| New to bDMARD | New to bDMARD RA patients with high and low cost share who continue or discontinue treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of patient cost share on discontinuation
Measured: Assessed from first prescription date and followed for 1-year
Secondary outcomes (4)
RA-related healthcare utilization and costs
Measured: Pre-index: 6-month period prior to the index drug date
All-cause healthcare utilization and costs
Measured: Pre-index: 6-month period prior to the index drug date
RA-related healthcare utilization and costs
Measured: Post-period: Index date+365 days
All-cause healthcare utilization and costs
Measured: Post-period: Index date+365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionSep 2010
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
- Retrospective
- Enrolment
- 3,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137851
- Sponsor's protocol ID
- IM101-256
- Status last verified
- Sep 2010
- First submitted
- 3 Jun 2010
- Last updated
- 1 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Patient Cost Sharing on Treatment Discontinuation Among Rheumatoid Arthritis Patients Treated With Biologic Disease Modifying Antirheumatic Drug (DMARD) Therapies
- ClinicalTrials.gov ID
- NCT01137851
- Acronym / sponsor ID
- IM101-256
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,940 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Jun 2010 (estimated)
- 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 to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with Rheumatoid Arthritis (RA)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New to bDMARD | – | –New to bDMARD RA patients with high and low cost share who continue or discontinue treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Commercial health plan members
Key inclusion criteria (6 listed)
- 18 to 64 years of age at index date
- Diagnosis of RA during the study period (ICD-9CM 714.xx)
- Evidence of at least one biologic DMARD of interest during the study timeframe
- Continuous enrollment during the study timeframe
- Both medical and pharmacy benefits
Key exclusion criteria (1 listed)
- Patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for Rituxan, IV etanercept, or IV adalimumab; or have Medicare or Medicaid during the study timeframe
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
Effect of patient cost share on discontinuation
Time frame: Assessed from first prescription date and followed for 1-year
4 secondary outcomes
RA-related healthcare utilization and costs
Time frame: Pre-index: 6-month period prior to the index drug date
All-cause healthcare utilization and costs
Time frame: Pre-index: 6-month period prior to the index drug date
RA-related healthcare utilization and costs
Time frame: Post-period: Index date+365 days
All-cause healthcare utilization and costs
Time frame: Post-period: Index date+365 days
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 1 Oct 2010.
- For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htmLink provided by the sponsor.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Bristol-Myers Squibb.
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 6 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 1 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Effect of patient cost share on discontinuation (time frame: Assessed from first prescription date and followed for 1-year). 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 1 Oct 2010.