ArthritisIMAGINE-RANCT01656278
An MRI-guided Treatment Strategy to Prevent Disease Progression in Patients With Rheumatoid Arthritis
A study testing Magnetic resonance imaging (MRI) and Conventional biochemical and clinical examinations in people with Arthritis and Arthritis, Rheumatoid, run by Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen at 9 sites in Denmark.
Trial summary
The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Arthritis, Rheumatoid, Joint Diseases
- What is being tested?
- Magnetic resonance imaging (MRI) and Conventional biochemical and clinical examinations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesDenmark
- Study dates
- Mar 2012to May 2017
- Phase
- Interventional
- 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
- Age > 18 years
- RA according to ACR (American College of Rheumatology)/EULAR (European League Against Rheumatism) 2010 criteria.
- Anti-CCP positivity
- Erosions on conventional X-ray of hands, wrists and/or feet
- No clinically swollen joints
- DAS28 (4 variable, CRP) < 3.2
Show all 14Show fewer
- DMARD monotherapy treatment OR combination treatment, in the form of 2- or 3-drug therapy. If the patient is undergoing 3-drug therapy, at least one of the preparations must be administered at less than the "maximum inclusion dose"*
- Unchanged anti-rheumatic treatment in the previous 6 weeks or more
- No previous treatment with biological medication
- No contra-indications for TNF-alpha-inhibiting treatment
- No contra-indications for MRI
- s-creatinine within normal range
- Ability and willingness to give written and oral informed consent and fulfil the requirements of the study programme with reference to the protocol
- Maximum "inclusion dose" is defined as: MTX 25 mg/week (or maximum tolerated dose if 25 mg/week is not tolerated), SSZ 2g/day (or maximum tolerated dose if 2 g/day is not tolerated) and HCQ 200 mg/day (or maximum tolerated dose if 200 mg/day is not tolerated)
Who cannot join
- Previous or current biological treatment
- Known intolerance to methotrexate treatment which means that the patient is not able to tolerate a minimum of MTX 7.5 mg (minimum dose).
- DMARD 3-drug therapy at maximum tolerated/maximum "inclusion dose"*
- I.m, intra-articular or i.v glucocorticoid administration ≤ 6 weeks prior to inclusion
- Oral glucocorticoid administration > 5 mg/day
- Changes in oral glucocorticoid dose < 3 months prior to inclusion
Show all 14Show fewer
- Myocrisin treatment
- Affected liver enzymes > 2 x the upper limit of normal at the time of screening
- Current and/or imminent wish to become pregnant
- Contra-indications for TNF-alpha-inhibiting treatment
- Contra-indications for MRI
- Known alcohol/drug abuse
- Inability to give informed consent
- Inability to cooperate with the study programme due to physical or mental reasons
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites
Dep. of Rheumatology Aarhus Hospital
Aarhus, 8600
Dep. of Rheumatology Frederiksberg Hospital
Copenhagen, 2000
Dep. of Rheumatology Glostrup Hospital
Copenhagen, 2600
Dep. of Rheumatology Gentofte Hospital
Copenhagen, 2900
Dep. of Rheumatology King Christian X´Hospital for Rheumatic Diseases
Gråsten, 6300
Department of Rheumatology University Hospital Vendsyssel
Hjørring, DK-9800
Dep. of rheumatology Odense Hospital
Odense, 5000
Dep. of Rheumatology Silkeborg Hospital
Silkeborg, 8600
Dep. of Rheumatology Slagelse Hospital
Slagelse, 4200
About this study
Official title: Does an MRI-guided Treatment Strategy Reduce Disease Activity and Progression in Patients With Rheumatoid Arthritis (RA): a Randomised Controlled Trial
The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis (RA).
Read the detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Patients typically experience pain, functional impairment and reduced quality of life, and are at risk of developing progressive joint damage. The disease primarily affects the small joints of the hands and feet. The current treatment strategy involves early and intensive treatment with close clinical follow up, which attempts to control the disease and avoid inflammation and thereby prevent pain, improve functional level and avoid joint damage. It is therefore important for optimal treatment of RA patients that methods used for diagnosis, disease monitoring and prognostication are highly sensitive. Erosive joint damage occurs early in the disease. Joint deformity is irreversible and causes serious functional impairment. Early and intensive treatment with close monitoring of the inflammation can slow the destructive disease and prevent function loss. However, it has been demonstrated that patients who are shown by conventional clinical and biochemical examination to have low disease activity or to be in remission can still have progressive joint damage. This demonstrates that current clinical/biochemical methods used in daily clinical practice are not sufficiently sensitive and other methods are required for the monitoring of disease activity and prognostication.
The presence of erosions (shown by X-ray examination) as well as anti-cyclic citrullinated peptide (anti-CCP) antibodies and bone marrow oedema (osteitis) on magnetic resonance imaging (MRI), are all independent predictors of subsequent radiographic progression. Bone marrow oedema has been shown to be the strongest independent predictor in early RA and MRI therefore has significant prognostic value.
It is therefore possible that supplementing conventional clinical and biochemical examinations of RA patients with MRI, and intensifying treatment where bone marrow oedema is present, will help reduce disease activity, avoid progressive joint damage and prevent function loss.
The current study is therefore based on the following hypothesis:
By supplementing conventional clinical and biochemical examination of RA patients with low disease activity/in remission with MRI and intensifying treatment in the case of sub-clinical inflammation as measured by the presence of bone marrow oedema, it is possible to prevent radiographic erosive progression, improve functional level and enable more patients to achieve clinical remission.
- Conditions
- Arthritis, Arthritis, Rheumatoid, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases
- Being tested
- Magnetic resonance imaging (MRI), Conventional biochemical and clinical examinations
- Keywords
- Arthritis, Rheumatoid/drug therapy, Arthritis, Rheumatoid/pathology, Disease Progression, Longitudinal Studies, Prospective Studies, Imaging, Magnetic Resonance, Remission Induction, Synovitis/immunology, Synovitis/pathology, Wrist Joint/pathology, Wrist Joint/physiopathology
- Medical subject headings
- Arthritis, Arthritis, Rheumatoid, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imaging (MRI)Procedure or surgery
Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one physically swollen joint and DAS28>3.2 AND/OR MRI-detected bone marrow oedema score > 0 (RAMRIS-score)
Conventional biochemical and clinical examinationsOther
Treatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one clinically swollen joint and DAS28>3.2
| Study group | Role | What they receive |
|---|---|---|
| Conventional biochemical and clinical examinations | Active comparator | Biochemical and clinical examinations Receives: Other: Conventional biochemical and clinical examinations |
| Conventional biochemical and clinical examinations and MRI. | Experimental | Biochemical and clinical examinations and MRI. Receives: Procedure: Magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28 remission (<2.6)
Measured: 24 month
No radiographic progression (assessed by the Sharp/vdHeijde method).
Measured: 24 month
Secondary outcomes (11)
No radiographic progression (Sharp/vdHeijde score).
No radiographic progression (Sharp/vdHeijde score) from 0-12 and 12-24 months and change in Sharp/vdHeijde score from 0-12, 0-24 and 12-24 months.
Measured: 24 month
No MRI erosion (RAMRIS) score
No progression in MRI erosion (RAMRIS) score from 0-12 and 12-24 months and change in MRI erosion (RAMRIS) score from 0-12, 0-24 and 12-24 months.
Measured: 24 month
MRI synovitis (RAMRIS) score
MRI synovitis (RAMRIS) score at 12 and 24 months
Measured: 24 months
MRI bone marrow oedema (RAMRIS) score
MRI bone marrow oedema (RAMRIS) score at 12 and 24 months
Measured: 24 months
HAQ score
Changes in HAQ score from 0-12 and 0-24 months
Measured: 24 month
SF-36 score
Changes in SF-36 score from 0-12 and 0-24 months
Measured: 24 month
EQ-5D score
Changes in EQ-5D score from 0-12 and 0-24 months
Measured: 24 month
ACR/EULAR 2011 remission
ACR/EULAR 2011 remission at 12 and 24 months
Measured: 24 month
DAS28
DAS28 at 12 and 24 month
Measured: 24 month
DAS28 remission (<2.6) at 12 months
Measured: 24 months
biomarker analyses
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen
- Sponsor type
- University, hospital or other
- Collaborators
- King Christian X´Hospital for Rheumatic Diseases, Slagelse Hospital, Glostrup University Hospital, Copenhagen, Abbott
- Responsible party
- Sponsor-investigator, Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen, King Christian X´Hospital for Rheumatic Diseases
- Investigators
- Kim Hørslev-Petersen, Professor, Principal investigator, King Christian X´Hospital for Rheumatic DiseasesSigne Møller-Bisgaard, MD, Study director, Dep. of Rheumatology, Rigshospitalet, GlostrupMikkel Østergaard, Professor, Study chair, Dep. of Rheumatology, Rigshospitalet, GlostrupBo Ejbjerg, MD, PhD, Study chair, Dep. of Rheumatology Slagelse HospitalMerete Hetland, MD, PhD, DMSci, Study chair, Dep. of Rheumatology, Rigshospitalet, Glostrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656278
- Sponsor's protocol ID
- IMAGINE-RA
- Acronym
- IMAGINE-RA
- Status last verified
- Jun 2017
- First submitted
- 5 Jul 2012
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Christensen R, Ornbjerg LM, Glinatsi D, Moller JM, Boesen M, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Larsen L, Jurik AG, Thomsen HS, Ostergaard M. Effect of initiating biologics compared to intensifying conventional DMARDs on clinical and MRI outcomes in established rheumatoid arthritis patients in clinical remission: Secondary analyses of the IMAGINE-RA trial. Scand J Rheumatol. 2022 Jul;51(4):268-278. doi: 10.1080/03009742.2021.1935312. Epub 2021 Sep 2.
PubMed 34474649Moller-Bisgaard S, Georgiadis S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Ornbjerg LM, Glinatsi D, Moller J, Boesen M, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Balding L, Jurik AG, Thomsen HS, Ostergaard M. Predictors of joint damage progression and stringent remission in patients with established rheumatoid arthritis in clinical remission. Rheumatology (Oxford). 2021 Jan 5;60(1):380-391. doi: 10.1093/rheumatology/keaa496.
PubMed 32929463Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Ornbjerg LM, Glinatsi D, Moller J, Boesen M, Christensen R, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Nielsen SM, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Balding L, Jurik AG, Thomsen HS, Ostergaard M. Effect of Magnetic Resonance Imaging vs Conventional Treat-to-Target Strategies on Disease Activity Remission and Radiographic Progression in Rheumatoid Arthritis: The IMAGINE-RA Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):461-472. doi: 10.1001/jama.2018.21362.
PubMed 30721294Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg BJ, Boesen M, Hetland ML, Christensen R, Moller J, Krogh NS, Stengaard-Pedersen K, Ostergaard M. Impact of a magnetic resonance imaging-guided treat-to-target strategy on disease activity and progression in patients with rheumatoid arthritis (the IMAGINE-RA trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:178. doi: 10.1186/s13063-015-0693-2.
PubMed 25896862
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does an MRI-guided Treatment Strategy Reduce Disease Activity and Progression in Patients With Rheumatoid Arthritis (RA): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01656278
- Acronym / sponsor ID
- IMAGINE-RA / IMAGINE-RA
- Conditions
- Arthritis, Arthritis, Rheumatoid, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases
- Keywords
- Arthritis, Rheumatoid/drug therapy, Arthritis, Rheumatoid/pathology, Disease Progression, Longitudinal Studies, Prospective Studies, Imaging, Magnetic Resonance, Remission Induction, Synovitis/immunology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Professor of Rheumatology, MD, DMSci, Kim Horslev-PetersenUniversity, hospital or other
- Collaborators
- King Christian X´Hospital for Rheumatic Diseases, Slagelse Hospital, Glostrup University Hospital, Copenhagen, Abbott
- Study start
- Mar 2012 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 2 Aug 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.
The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis (RA).
Detailed description
Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Patients typically experience pain, functional impairment and reduced quality of life, and are at risk of developing progressive joint damage. The disease primarily affects the small joints of the hands and feet. The current treatment strategy involves early and intensive treatment with close clinical follow up, which attempts to control the disease and avoid inflammation and thereby prevent pain, improve functional level and avoid joint damage. It is therefore important for optimal treatment of RA patients that methods used for diagnosis, disease monitoring and prognostication are highly sensitive. Erosive joint damage occurs early in the disease. Joint deformity is irreversible and causes serious functional impairment. Early and intensive treatment with close monitoring of the inflammation can slow the destructive disease and prevent function loss. However, it has been demonstrated that patients who are shown by conventional clinical and biochemical examination to have low disease activity or to be in remission can still have progressive joint damage. This demonstrates that current clinical/biochemical methods used in daily clinical practice are not sufficiently sensitive and other methods are required for the monitoring of disease activity and prognostication.
The presence of erosions (shown by X-ray examination) as well as anti-cyclic citrullinated peptide (anti-CCP) antibodies and bone marrow oedema (osteitis) on magnetic resonance imaging (MRI), are all independent predictors of subsequent radiographic progression. Bone marrow oedema has been shown to be the strongest independent predictor in early RA and MRI therefore has significant prognostic value.
It is therefore possible that supplementing conventional clinical and biochemical examinations of RA patients with MRI, and intensifying treatment where bone marrow oedema is present, will help reduce disease activity, avoid progressive joint damage and prevent function loss.
The current study is therefore based on the following hypothesis:
By supplementing conventional clinical and biochemical examination of RA patients with low disease activity/in remission with MRI and intensifying treatment in the case of sub-clinical inflammation as measured by the presence of bone marrow oedema, it is possible to prevent radiographic erosive progression, improve functional level and enable more patients to achieve clinical remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional biochemical and clinical examinations | Active comparator | Other: Conventional biochemical and clinical examinationsBiochemical and clinical examinations |
| Conventional biochemical and clinical examinations and MRI. | Experimental | Procedure: Magnetic resonance imaging (MRI)Biochemical and clinical examinations and MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age > 18 years
- RA according to ACR (American College of Rheumatology)/EULAR (European League Against Rheumatism) 2010 criteria.
- Anti-CCP positivity
- Erosions on conventional X-ray of hands, wrists and/or feet
- No clinically swollen joints
Key exclusion criteria (14 listed)
- Previous or current biological treatment
- Known intolerance to methotrexate treatment which means that the patient is not able to tolerate a minimum of MTX 7.5 mg (minimum dose).
- DMARD 3-drug therapy at maximum tolerated/maximum "inclusion dose"*
- I.m, intra-articular or i.v glucocorticoid administration ≤ 6 weeks prior to inclusion
- Oral glucocorticoid administration > 5 mg/day
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 |
|---|---|---|
| Magnetic resonance imaging (MRI)Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one physically swollen joint and DAS28>3.2 AND/OR MRI-detected bone marrow oedema score > 0 (RAMRIS-score) | Procedure or surgery | Conventional biochemical and clinical examinations and MRI. |
| Conventional biochemical and clinical examinationsTreatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one clinically swollen joint and DAS28>3.2 | Other | Conventional biochemical and clinical examinations |
Primary outcome
DAS28 remission (<2.6)
Time frame: 24 month
No radiographic progression (assessed by the Sharp/vdHeijde method).
Time frame: 24 month
11 secondary outcomes
No radiographic progression (Sharp/vdHeijde score).
Time frame: 24 month
No MRI erosion (RAMRIS) score
Time frame: 24 month
MRI synovitis (RAMRIS) score
Time frame: 24 months
MRI bone marrow oedema (RAMRIS) score
Time frame: 24 months
HAQ score
Time frame: 24 month
SF-36 score
Time frame: 24 month
EQ-5D score
Time frame: 24 month
ACR/EULAR 2011 remission
Time frame: 24 month
DAS28
Time frame: 24 month
DAS28 remission (<2.6) at 12 months
Time frame: 24 months
biomarker analyses
Time frame: 24 month
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 23 Jun 2017.
- Derived from this study: PubMed 34474649Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Christensen R, Ornbjerg LM, Glinatsi D, Moller JM, Boesen M, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Larsen L, Jurik AG, Thomsen HS, Ostergaard M. Effect of initiating biologics compared to intensifying conventional DMARDs on clinical and MRI outcomes in established rheumatoid arthritis patients in clinical remission: Secondary analyses of the IMAGINE-RA trial. Scand J Rheumatol. 2022 Jul;51(4):268-278. doi: 10.1080/03009742.2021.1935312. Epub 2021 Sep 2.
- Derived from this study: PubMed 32929463Moller-Bisgaard S, Georgiadis S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Ornbjerg LM, Glinatsi D, Moller J, Boesen M, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Balding L, Jurik AG, Thomsen HS, Ostergaard M. Predictors of joint damage progression and stringent remission in patients with established rheumatoid arthritis in clinical remission. Rheumatology (Oxford). 2021 Jan 5;60(1):380-391. doi: 10.1093/rheumatology/keaa496.
- Derived from this study: PubMed 30721294Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg B, Hetland ML, Ornbjerg LM, Glinatsi D, Moller J, Boesen M, Christensen R, Stengaard-Pedersen K, Madsen OR, Jensen B, Villadsen JA, Hauge EM, Bennett P, Hendricks O, Asmussen K, Kowalski M, Lindegaard H, Nielsen SM, Bliddal H, Krogh NS, Ellingsen T, Nielsen AH, Balding L, Jurik AG, Thomsen HS, Ostergaard M. Effect of Magnetic Resonance Imaging vs Conventional Treat-to-Target Strategies on Disease Activity Remission and Radiographic Progression in Rheumatoid Arthritis: The IMAGINE-RA Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):461-472. doi: 10.1001/jama.2018.21362.
- Derived from this study: PubMed 25896862Moller-Bisgaard S, Horslev-Petersen K, Ejbjerg BJ, Boesen M, Hetland ML, Christensen R, Moller J, Krogh NS, Stengaard-Pedersen K, Ostergaard M. Impact of a magnetic resonance imaging-guided treat-to-target strategy on disease activity and progression in patients with rheumatoid arthritis (the IMAGINE-RA trial): study protocol for a randomized controlled trial. Trials. 2015 Apr 21;16:178. doi: 10.1186/s13063-015-0693-2.
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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.
Kim Hørslev-Petersen, Professor principal investigator
King Christian X´Hospital for Rheumatic Diseases
Signe Møller-Bisgaard, MD study director
Dep. of Rheumatology, Rigshospitalet, Glostrup
Mikkel Østergaard, Professor study chair
Dep. of Rheumatology, Rigshospitalet, Glostrup
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging (MRI) and Conventional biochemical and clinical examinations in people with Arthritis and Arthritis, Rheumatoid, run by Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen at 9 sites in Denmark.
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 14 inclusion and 14 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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark. 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?
DAS28 remission (<2.6) (time frame: 24 month). The study lists 2 primary outcomes in all. 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 NCT01656278, which also lists 4 linked publications.
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 23 Jun 2017.