Rheumatoid ArthritisPhase 4NCT00233558
Open-Label Steroid Reduction Study of Adalimumab With Methotrexate in Patients With Active Rheumatoid Arthritis
A Phase 4 study testing adalimumab (up to 9 months exposure) and methotrexate in people with Rheumatoid Arthritis, run by Abbott at 1 site in United States.
Trial summary
The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- adalimumab (up to 9 months exposure) and methotrexate
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to not given
- Phase
- Phase 4
- 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
Who may be able to join
- Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
Who cannot join
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Medical Information - Abbott
North Chicago, Illinois, 60064
About this study
Official title: Multicentre, Randomised, Open Label Study Comparing a "Scheduled Steroid Reduction Strategy" Versus a Free Steroid Reduction Strategy (Physician's Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months
The purpose of the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX
- Conditions
- Rheumatoid Arthritis
- Being tested
- adalimumab (up to 9 months exposure), methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab (up to 9 months exposure)Drug
methotrexateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Corticoid reduction and DAS 28
Secondary outcomes (3)
Patient reported outcomes
Clinical response indicators
Safety parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startJun 2005
Why it stopped: Study terminated due to low subject enrollment. Safety results consistent with product label.
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.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233558
- Sponsor's protocol ID
- FRAN-04-002
- Status last verified
- Apr 2007
- First submitted
- 13 Sep 2005
- Last updated
- 24 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomised, Open Label Study Comparing a "Scheduled Steroid Reduction Strategy" Versus a Free Steroid Reduction Strategy (Physician's Usual Practice for Reducing Steroids) in Patients With Active RA Treated With Humira 40 mg Eow + MTX During 9 Months
- ClinicalTrials.gov ID
- NCT00233558
- Acronym / sponsor ID
- FRAN-04-002
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to low subject enrollment. Safety results consistent with product label.
- Enrolment
- 160 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- First posted
- 6 Oct 2005 (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 the study is to evaluate the clinical efficacy of scheduled versus free reduction of steroid treatment in patients with active RA treated with adalimumab + MTX
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
- Subject has a diagnosis of rheumatoid arthritis as defined by the 1987-revised ACR criteria
Key exclusion criteria (2 listed)
- Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Female subject who is pregnant or breast-feeding or considering becoming pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab (up to 9 months exposure) | Drug | – |
| methotrexate | Drug | – |
Primary outcome
Corticoid reduction and DAS 28
3 secondary outcomes
Patient reported outcomes
Clinical response indicators
Safety parameters
Results and safety
The study was stopped early (reason given: Study terminated due to low subject enrollment. Safety results consistent with product label.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2007.
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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.
Global Medical Information study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adalimumab (up to 9 months exposure) and methotrexate in people with Rheumatoid Arthritis, run by Abbott at 1 site in United States.
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: stopped early, as of the sponsor's last update on 24 Apr 2007. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to low subject enrollment. Safety results consistent with product label.). Results are not available in the source record.
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?
Corticoid reduction and DAS 28. 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 24 Apr 2007.