Rheumatoid ArthritisPhase 4NCT00396747
A Comparison of Methotrexate Alone or Combined to Infliximab or to Pulse Methylprednisolone in Early Rheumatoid Arthritis: A Magnetic Resonance Imaging Study
A Phase 4 study testing Infliximab, methylprednisolone, methotrexate, Methotrexate and Methotrexate + Methylprednisolone in people with Rheumatoid Arthritis, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients. 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?
- Infliximab, methylprednisolone, methotrexate, Methotrexate and Methotrexate + Methylprednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2003to Sep 2005
- 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
- Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count [SJC] ≥ 6 [by the 66 joints count] and a tender joint count [TJC] ≥ 8 [by the 68 joints count]) and had not been treated with MTX before.
- Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count [SJC] ≥ 6 [by the 66 joints count] and a tender joint count [TJC] ≥ 8 [by the 68 joints count]) and had not been treated with MTX before.
Who cannot join
- Exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with GC for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 DMARDs, MTX, IV MP pulse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.
Read the detailed description
The effects of Glucocorticoïds and Infliximab have never been compared in early RA using MRI as primary outcome measure. In the current study, we compare the effects of MTX alone or in combination with intravenous (IV) methylprednisolone (MP) pulse therapy or IFX on MRI-detected synovitis, bone edema and erosive changes in early RA patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Infliximab, methylprednisolone, methotrexate, Methotrexate, Methotrexate + Methylprednisolone, Methotrexate + Infliximab
- Keywords
- Early rheumatoid arthritis,, glucocorticoids,, pulse therapy,, infliximab,, TNF blockade
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infliximab, methylprednisolone, methotrexateDrug
MethotrexateDrug
Methotrexate + MethylprednisoloneDrug
Methotrexate + InfliximabDrug
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Methotrexate Receives: Drug: Infliximab, methylprednisolone, methotrexate; Drug: Methotrexate |
| B | Active comparator | MTX + MP Receives: Drug: Infliximab, methylprednisolone, methotrexate; Drug: Methotrexate + Methylprednisolone |
| C | Active comparator | MTX + IFX Receives: Drug: Infliximab, methylprednisolone, methotrexate; Drug: Methotrexate + Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI synovitis, bone edema and erosions score
Measured: baseline, week 18 and 52
Secondary outcomes (2)
Efficacy (DAS Score, ACR response)
Measured: every 2 months
Side effects
Measured: every visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startJun 2003
- Study completionSep 2005
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 Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Durez, MD, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396747
- Sponsor's protocol ID
- CIERA
- Status last verified
- Oct 2007
- First submitted
- 6 Nov 2006
- Last updated
- 19 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Durez P, Malghem J, Nzeusseu Toukap A, Depresseux G, Lauwerys BR, Westhovens R, Luyten FP, Corluy L, Houssiau FA, Verschueren P. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum. 2007 Dec;56(12):3919-27. doi: 10.1002/art.23055.
PubMed 18050189
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Early RA: a Randomized Magnetic Resonance Imaging Study Comparing the Effects of Methotrexate Alone or in Combination With Infliximab or Intravenous Pulse Methylprednisolone
- ClinicalTrials.gov ID
- NCT00396747
- Acronym / sponsor ID
- CIERA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Early rheumatoid arthritis,, glucocorticoids,, pulse therapy,, infliximab,, TNF blockade
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 7 Nov 2006 (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 compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on MRI-detected synovitis, bone edema and erosive changes in early rheumatoid arthritis (RA) patients.
Detailed description
The effects of Glucocorticoïds and Infliximab have never been compared in early RA using MRI as primary outcome measure. In the current study, we compare the effects of MTX alone or in combination with intravenous (IV) methylprednisolone (MP) pulse therapy or IFX on MRI-detected synovitis, bone edema and erosive changes in early RA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Infliximab, methylprednisolone, methotrexate, Drug: MethotrexateMethotrexate |
| B | Active comparator | Drug: Infliximab, methylprednisolone, methotrexate, Drug: Methotrexate + MethylprednisoloneMTX + MP |
| C | Active comparator | Drug: Infliximab, methylprednisolone, methotrexate, Drug: Methotrexate + InfliximabMTX + IFX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count [SJC] ≥ 6 [by the 66 joints count] and a tender joint count [TJC] ≥ 8 [by the 68 joints count]) and had not been treated with MTX before.
- Patients were eligible for this study if they met the American Rheumatism Association classification criteria for RA (9), had a disease duration inferior to one year, suffered from active disease (defined as the presence of a swollen joint count [SJC] ≥ 6 [by the 66 joints count] and a tender joint count [TJC] ≥ 8 [by the 68 joints count]) and had not been treated with MTX before.
Key exclusion criteria (1 listed)
- Exclusion criteria included past/current history of tuberculosis, congestive heart disease, past treatment with GC for more than 3 months (and not during the 4 weeks before inclusion), previous treatment with more than 2 DMARDs, MTX, IV MP pulse.
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 |
|---|---|---|
| Infliximab, methylprednisolone, methotrexate | Drug | A, B, C |
| Methotrexate | Drug | A |
| Methotrexate + Methylprednisolone | Drug | B |
| Methotrexate + Infliximab | Drug | C |
Primary outcome
MRI synovitis, bone edema and erosions score
Time frame: baseline, week 18 and 52
2 secondary outcomes
Efficacy (DAS Score, ACR response)
Time frame: every 2 months
Side effects
Time frame: every visit
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 19 Oct 2007.
- Derived from this study: PubMed 18050189Durez P, Malghem J, Nzeusseu Toukap A, Depresseux G, Lauwerys BR, Westhovens R, Luyten FP, Corluy L, Houssiau FA, Verschueren P. Treatment of early rheumatoid arthritis: a randomized magnetic resonance imaging study comparing the effects of methotrexate alone, methotrexate in combination with infliximab, and methotrexate in combination with intravenous pulse methylprednisolone. Arthritis Rheum. 2007 Dec;56(12):3919-27. doi: 10.1002/art.23055.
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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.
Patrick Durez, MD principal investigator
Université Catholique de Louvain
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 Infliximab, methylprednisolone, methotrexate, Methotrexate and Methotrexate + Methylprednisolone in people with Rheumatoid Arthritis, run by Université Catholique de Louvain at 1 site in Belgium.
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 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 19 Oct 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 Belgium. 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 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?
MRI synovitis, bone edema and erosions score (time frame: baseline, week 18 and 52). 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 NCT00396747, 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 19 Oct 2007.