Rheumatoid ArthritisMAINTAINNCT01692899
Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
An observational study of Rheumatoid Arthritis, run by Pfizer.
Trial summary
To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor α inhibitors (TNFi). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 780 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Sep 2011
- 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: RA defined by the 1987 ACR criteria [18]; first TNFα inhibitor prescribed in the previously mentioned period; TNFα inhibitor prescribed as first-line biotherapy; and patients had undergone at least one evaluation in the center after treatment initiation. Patients were excluded if: they had previously received another biotherapy; the TNFα inhibitor was prescribed in an RCT; or they refused to participate.
Who may be able to join
- RA defined by the 1987 ACR criteria [18]
- first TNFα inhibitor prescribed in the previously mentioned period
- TNFα inhibitor prescribed as first-line biotherapy
- undergone at least one evaluation in the center after treatment initiation
Who cannot join
- previously received another biotherapy
- TNFα inhibitor was prescribed in an RCT
- refused to participate
About this study
To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor α inhibitors (TNFi).
Read the detailed description
In this retrolective, multicentric study, medical charts of RA patients starting TNFi between March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after adjustment using a Cox model. Factors associated with better retention were identified by multivariate analysis. Medical charts of all patients with RA starting a first TNFα inhibitor therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April 30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2 rheumatologist investigators
- Conditions
- Rheumatoid Arthritis
- Keywords
- Retention Rates, of Adalimumab, Etanercept and Infliximab, as First and Second-Line Biotherapy, in Patients with Rheumatoid Arthritis, in Daily Practice., TNF inhibitors, biotherapy, retrospective study
- 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 |
|---|---|---|
| Etanercept | Etanercept: administered as first line biotherapy in RA during the period of the study | |
| Adalimumab | Adalimumab: administered as first line biotherpy in RA during the period of the study | |
| Infliximab | Infliximab: administered as first line biotherpy in RA during the period of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA
Measured: 2 years
Secondary outcomes (4)
Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)
Measured: 4 years
Causes of discontinuing these treatments
Measured: 4 years
Determine the factors associated with better retention of the first TNFα inhibitors
Measured: 4 years
Compare retention rates of possible second-line TNFα inhibitors
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Time perspective
- Retrospective
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- scientific steering committee of KOL in rheumatology
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692899
- Sponsor's protocol ID
- NRB1800007
- Other IDs
- B1801356
- Acronym
- MAINTAIN
- Status last verified
- Sep 2012
- First submitted
- 21 Sep 2012
- Last updated
- 25 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, Le Loet X, Combe B. Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Joint Bone Spine. 2014 Jul;81(4):352-9. doi: 10.1016/j.jbspin.2014.02.014. Epub 2014 Apr 8.
PubMed 24721422
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention Rates of Adalimumab, Etanercept and Infliximab as First and Second-Line Biotherapy in Patients With Rheumatoid Arthritis in Daily Practice
- ClinicalTrials.gov ID
- NCT01692899
- Acronym / sponsor ID
- MAINTAIN / NRB1800007
- Conditions
- Rheumatoid Arthritis
- Keywords
- Retention Rates, of Adalimumab, Etanercept and Infliximab, as First and Second-Line Biotherapy, in Patients with Rheumatoid Arthritis, in Daily Practice., TNF inhibitors, biotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- scientific steering committee of KOL in rheumatology
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Sep 2012 (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.
To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line tumor necrosis factor α inhibitors (TNFi).
Detailed description
In this retrolective, multicentric study, medical charts of RA patients starting TNFi between March 2005 and April 2009 were reviewed, with follow-up between 2 and 6 years. The retention rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after adjustment using a Cox model. Factors associated with better retention were identified by multivariate analysis. Medical charts of all patients with RA starting a first TNFα inhibitor therapy between March 1, 2005 (start of commercialization of adalimumab in France) and April 30, 2009 (allowing at least 2 years of follow-up) were systematically reviewed in detail by 2 rheumatologist investigators
Study design
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Etanercept | – | –Etanercept: administered as first line biotherapy in RA during the period of the study |
| Adalimumab | – | –Adalimumab: administered as first line biotherpy in RA during the period of the study |
| Infliximab | – | –Infliximab: administered as first line biotherpy in RA during the period of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA defined by the 1987 ACR criteria [18]; first TNFα inhibitor prescribed in the previously mentioned period; TNFα inhibitor prescribed as first-line biotherapy; and patients had undergone at least one evaluation in the center after treatment initiation. Patients were excluded if: they had previously received another biotherapy; the TNFα inhibitor was prescribed in an RCT; or they refused to participate.
Key inclusion criteria (4 listed)
- RA defined by the 1987 ACR criteria [18]
- first TNFα inhibitor prescribed in the previously mentioned period
- TNFα inhibitor prescribed as first-line biotherapy
- undergone at least one evaluation in the center after treatment initiation
Key exclusion criteria (3 listed)
- previously received another biotherapy
- TNFα inhibitor was prescribed in an RCT
- refused to participate
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
Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA
Time frame: 2 years
4 secondary outcomes
Compare retention rates of TNFα inhibitor monoclonal antibodies (adalimumab and infliximab) and the soluble receptor (etanercept)
Time frame: 4 years
Causes of discontinuing these treatments
Time frame: 4 years
Determine the factors associated with better retention of the first TNFα inhibitors
Time frame: 4 years
Compare retention rates of possible second-line TNFα inhibitors
Time frame: 4 years
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 25 Sep 2012.
- Derived from this study: PubMed 24721422Frazier-Mironer A, Dougados M, Mariette X, Cantagrel A, Deschamps V, Flipo RM, Logeart I, Schaeverbeke T, Sibilia J, Le Loet X, Combe B. Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice. Joint Bone Spine. 2014 Jul;81(4):352-9. doi: 10.1016/j.jbspin.2014.02.014. Epub 2014 Apr 8.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Pfizer.
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 4 inclusion and 3 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 25 Sep 2012. 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?
Compare retention rates of adalimumab, etanercept and infliximab administered as first-line biologic therapy in RA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692899, which also lists 1 linked publication.
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 25 Sep 2012.