Inflammatory ArthritisPhase 4MRxNCT00808496
The Effect of Biannual Monitoring With Magnetic Resonance Imaging (MRI), X-ray, or Usual Care on Treatment for Inflammatory Arthritis
A Phase 4 study testing MRI and Radiography in people with Inflammatory Arthritis, run by McMaster University at 1 site in Canada.
Trial summary
Inflammatory arthritis is a major cause of permanent joint damage. Joint damage causes functional disability and physical deformity. Many inflammatory arthritis patients develop permanent joint damage within the first two years of disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- MRI and Radiography
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Apr 2013
- 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
- At least 18 years of age at study enrollment.
- At least three swollen joints; OR,
- Metacarpophalangeal joint(s) positive squeeze test; OR,
- Metatarsophalangeal joint(s) positive squeeze test; OR,
- At least 30 minutes of self-reported morning stiffness.
- At least six weeks of self-reported symptom duration.
Who cannot join
- Self-reported symptom onset prior to 17 years of age.
- Medical history of juvenile arthritis
- Evidence of viral arthritis
- A concomitant condition with medical priority over inflammatory arthritis, or that contraindicates treatment with DMARDs excluding sulfa allergy or medically controlled, non-terminal liver disease.
- Refusal to receive DMARD treatment
- Patients with a psychological deficit, or diminished capacity to provide independent, informed consent
Show all 9Show fewer
- Any contraindication to MRI or x-ray
- Current or planned pregnancy
- Lactation
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University, Division of Rheumatology
Hamilton, Ontario, L8N 1Y2
About this study
Official title: A Double Blind Randomized Controlled Trial to Compare Biannual Peripheral Magnetic Resonance Imaging, Radiography, and Standard of Care on Pharmacotherapeutic Escalation in Inflammatory Arthritis
Inflammatory arthritis is a major cause of permanent joint damage. Joint damage causes functional disability and physical deformity. Many inflammatory arthritis patients develop permanent joint damage within the first two years of disease. Early, aggressive treatment with drugs called disease-modifying antirheumatic drugs (DMARDs) is known to reduce how quickly this damage occurs. Sometimes, however, even when patients' symptoms are under control, the disease continues to cause joint damage.
This study will determine if magnetic resonance imaging (also known as 'MRI') conducted every six months provides arthritis specialists with information to help them better treat peripheral inflammatory arthritis patients over the first two years of care. The effect of MRI will be compared to 1) the use of x-ray every six months; and, 2) the frequency at which these tests are usually used. The study will also determine if differences in treatment between the three groups result in differences in the well-being of patients.
Read more
A total of 186 patients with early signs of inflammatory arthritis will be studied. All participants will have an MRI and x-ray conducted every six months. One-third of participants (62 in total) will only have MRI information sent to their arthritis specialist (MRI group); 62 will have x-ray information sent (X-ray group); and, the remaining 62 will have x-ray information sent only when ordered by the arthritis specialist (Usual Care group). Negative disease progression reports will be sent to the arthritis specialist unless intervention allocation-specific disease progression is detected. In which case, a report blinded to imaging modality will be sent indicating the detection of disease progression relative to the last timepoint of progression, or baseline, as applicable. At any point in the study, the arthritis specialist can request a clinical MRI or x-ray for any participant.
Neither the participants nor their doctors will know to which group they are assigned. A computer program will randomly assign participants to one of the three groups using a technique called minimization. This technique accounts for differences between participants that are known to effect disease progression and treatment decisions. Using this technique, participants with similar disease will be evenly distributed between the three groups.
The results of this study will have a direct impact on care for new inflammatory arthritis patients. It will determine the benefits, if any, of regular monitoring of disease progression with MRI or x-ray. Using tests proven to help treatment decision-making, arthritis specialists will improve the care provided to new inflammatory arthritis patients.
Read the detailed description
The proposed project is a double-blinded randomized-controlled trial to determine if biannual monitoring of inflammatory arthritis disease progression with 1.0T peripheral magnetic resonance imaging (pMRI) of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline compared to conventional radiography of both hands and wrists, or standard of care, alters the frequency of pharmacological treatment escalation at two years. A sample size of 186 (62 per group) is required to determine mean differences in the rate of pharmacological treatment escalation between the three groups with 90% power at a 5% level of significance, assuming a 5% spontaneous remission rate, 15% missing data, and 5% annual attrition.
- Conditions
- Inflammatory Arthritis
- Being tested
- MRI, Radiography, Standard of Care
- Keywords
- Magnetic resonance imaging, Radiography, Randomized controlled trial, Antirheumatic agents
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Also called Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)
Biannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline. Scored using the Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS).
MRI intervention group also undergoes radiography imaging. Only protocol determined smallest detectable changes on MRI reported.
RadiographyOther
Also called Diagnostic Imaging: Conventional radiography.
Biannual disease progression monitoring with radiography of both hands and wrists. Scored using the van der Heijde-modified Sharp score.
Radiography intervention group also undergoes MRI imaging. Only protocol determined smallest detectable changes on radiography reported.
Standard of CareOther
Also called Placebo control: see MRI and radiography interventions.
Diagnostic imaging results (MRI or radiography) reported upon requisition. Standard of Care intervention group undergoes both MRI and radiography imaging. Upon requisition of either MRI or radiography, radiology reports are delivered as per institutional standard of care
| Study group | Role | What they receive |
|---|---|---|
| MRI | Experimental | Biannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline. Receives: Other: MRI |
| Radiography | Active comparator | Biannual disease progression monitoring with radiography of both hands and wrists. Receives: Other: Radiography |
| Standard of Care | Placebo comparator | Diagnostic imaging results (MRI or radiography) reported to upon requisition. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of antirheumatic treatment escalations.
Measured: Two years
Secondary outcomes (9)
Change in van der Heijde-modified Sharp score of the hands and feet.
Measured: Two years
Change in 28-joint disease activity score (DAS28)
Measured: Two years
Change in health assessment questionnaire (HAQ) score
Measured: Two years
Change in Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS)
Measured: Two years
Change in health utility index - mark 3 (HUI-III)
Measured: Two years
Change in EQ-5D
Measured: Two years
Number of smallest detectable changes
Measured: Two years
Change in the proportion of participants with radiography-determined erosions of the hands, wrists, or feet
Measured: Two years
Change in the number of radiography-determined erosions of the hands, wrists or feet
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startJun 2009
- Primary completionOct 2012 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Tavares, McMaster University
- Investigators
- Ruben Tavares, MBt MSc CCRA, Principal investigator, McMaster UniversityJonathan D Adachi, MD FRCPC, Study chair, McMaster UniversityMaggie J Larche, MD PhD, Study director, McMaster UniversityColin E Webber, PhD CCPM, Study director, McMaster UniversityNaveen Parasu, MD FRCPC, Study director, McMaster UniversityKaren A Beattie, PhD, Study director, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808496
- Sponsor's protocol ID
- 200901
- Acronym
- MRx
- Status last verified
- Oct 2011
- First submitted
- 12 Dec 2008
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown AK, Conaghan PG, Karim Z, Quinn MA, Ikeda K, Peterfy CG, Hensor E, Wakefield RJ, O'Connor PJ, Emery P. An explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis. Arthritis Rheum. 2008 Oct;58(10):2958-67. doi: 10.1002/art.23945.
PubMed 18821687Schiff MH, Hobbs KF, Gensler T, Keenan GF. A retrospective analysis of low-field strength magnetic resonance imaging and the management of patients with rheumatoid arthritis. Curr Med Res Opin. 2007 May;23(5):961-8. doi: 10.1185/030079907x178892.
PubMed 17519063McQueen FM, Stewart N, Crabbe J, Robinson E, Yeoman S, Tan PL, McLean L. Magnetic resonance imaging of the wrist in early rheumatoid arthritis reveals progression of erosions despite clinical improvement. Ann Rheum Dis. 1999 Mar;58(3):156-63. doi: 10.1136/ard.58.3.156.
PubMed 10364913Olech E, Freeston JE, Conaghan PG, Hensor EM, Emery P, Yocum D. Using extremity magnetic resonance imaging to assess and monitor early rheumatoid arthritis: the optimal joint combination to be scanned in clinical practice. J Rheumatol. 2008 Apr;35(4):580-3. Epub 2008 Mar 1.
PubMed 18322995Xie X, Webber CE, Adachi JD, O'Neill J, Inglis D, Bobba RS, Wu H. Quantitative, small bore, 1 Tesla, magnetic resonance imaging of the hands of patients with rheumatoid arthritis. Clin Exp Rheumatol. 2008 Sep-Oct;26(5):860-5.
PubMed 19032820van der Heijde DM, van Riel PL, Nuver-Zwart IH, Gribnau FW, vad de Putte LB. Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis. Lancet. 1989 May 13;1(8646):1036-8. doi: 10.1016/s0140-6736(89)92442-2.
PubMed 2565997Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.
PubMed 4597226Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, Paulus HE, Mudano A, Pisu M, Elkins-Melton M, Outman R, Allison JJ, Suarez Almazor M, Bridges SL Jr, Chatham WW, Hochberg M, MacLean C, Mikuls T, Moreland LW, O'Dell J, Turkiewicz AM, Furst DE; American College of Rheumatology. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008 Jun 15;59(6):762-84. doi: 10.1002/art.23721. No abstract available.
PubMed 18512708Emery P, Breedveld FC, Dougados M, Kalden JR, Schiff MH, Smolen JS. Early referral recommendation for newly diagnosed rheumatoid arthritis: evidence based development of a clinical guide. Ann Rheum Dis. 2002 Apr;61(4):290-7. doi: 10.1136/ard.61.4.290.
PubMed 11874828Tavares R, Beattie KA, Bensen WG, Bobba RS, Cividino AA, Finlay K, Goeree R, Hart LE, Jurriaans E, Larche MJ, Parasu N, Tarride JE, Webber CE, Adachi JD. A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial. Trials. 2014 Jul 5;15:268. doi: 10.1186/1745-6215-15-268.
PubMed 24997587
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Randomized Controlled Trial to Compare Biannual Peripheral Magnetic Resonance Imaging, Radiography, and Standard of Care on Pharmacotherapeutic Escalation in Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT00808496
- Acronym / sponsor ID
- MRx / 200901
- Conditions
- Inflammatory Arthritis
- Keywords
- Magnetic resonance imaging, Radiography, Randomized controlled trial, Antirheumatic agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 15 Dec 2008 (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.
Inflammatory arthritis is a major cause of permanent joint damage. Joint damage causes functional disability and physical deformity. Many inflammatory arthritis patients develop permanent joint damage within the first two years of disease. Early, aggressive treatment with drugs called disease-modifying antirheumatic drugs (DMARDs) is known to reduce how quickly this damage occurs. Sometimes, however, even when patients' symptoms are under control, the disease continues to cause joint damage.
This study will determine if magnetic resonance imaging (also known as 'MRI') conducted every six months provides arthritis specialists with information to help them better treat peripheral inflammatory arthritis patients over the first two years of care. The effect of MRI will be compared to 1) the use of x-ray every six months; and, 2) the frequency at which these tests are usually used. The study will also determine if differences in treatment between the three groups result in differences in the well-being of patients.
A total of 186 patients with early signs of inflammatory arthritis will be studied. All participants will have an MRI and x-ray conducted every six months. One-third of participants (62 in total) will only have MRI information sent to their arthritis specialist (MRI group); 62 will have x-ray information sent (X-ray group); and, the remaining 62 will have x-ray information sent only when ordered by the arthritis specialist (Usual Care group). Negative disease progression reports will be sent to the arthritis specialist unless intervention allocation-specific disease progression is detected. In which case, a report blinded to imaging modality will be sent indicating the detection of disease progression relative to the last timepoint of progression, or baseline, as applicable. At any point in the study, the arthritis specialist can request a clinical MRI or x-ray for any participant.
Neither the participants nor their doctors will know to which group they are assigned. A computer program will randomly assign participants to one of the three groups using a technique called minimization. This technique accounts for differences between participants that are known to effect disease progression and treatment decisions. Using this technique, participants with similar disease will be evenly distributed between the three groups.
The results of this study will have a direct impact on care for new inflammatory arthritis patients. It will determine the benefits, if any, of regular monitoring of disease progression with MRI or x-ray. Using tests proven to help treatment decision-making, arthritis specialists will improve the care provided to new inflammatory arthritis patients.
Detailed description
The proposed project is a double-blinded randomized-controlled trial to determine if biannual monitoring of inflammatory arthritis disease progression with 1.0T peripheral magnetic resonance imaging (pMRI) of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline compared to conventional radiography of both hands and wrists, or standard of care, alters the frequency of pharmacological treatment escalation at two years. A sample size of 186 (62 per group) is required to determine mean differences in the rate of pharmacological treatment escalation between the three groups with 90% power at a 5% level of significance, assuming a 5% spontaneous remission rate, 15% missing data, and 5% annual attrition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MRI | Experimental | Other: MRIBiannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline. |
| Radiography | Active comparator | Other: RadiographyBiannual disease progression monitoring with radiography of both hands and wrists. |
| Standard of Care | Placebo comparator | Other: Standard of CareDiagnostic imaging results (MRI or radiography) reported to upon requisition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age at study enrollment.
- At least three swollen joints; OR,
- Metacarpophalangeal joint(s) positive squeeze test; OR,
- Metatarsophalangeal joint(s) positive squeeze test; OR,
- At least 30 minutes of self-reported morning stiffness.
Key exclusion criteria (9 listed)
- Self-reported symptom onset prior to 17 years of age.
- Medical history of juvenile arthritis
- Evidence of viral arthritis
- A concomitant condition with medical priority over inflammatory arthritis, or that contraindicates treatment with DMARDs excluding sulfa allergy or medically controlled, non-terminal liver disease.
- Refusal to receive DMARD treatment
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 |
|---|---|---|
| MRIAlso: Diagnostic imaging: 1T pMRI (OrthOne, ONI Medical Systems)Biannual disease progression monitoring with peripheral magnetic resonance imaging of the 2nd to 5th metacarpophalangeal joints of the worst-effected or dominant hand at baseline. Scored using the Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS). MRI intervention group also undergoes radiography imaging. Only protocol determined smallest detectable changes on MRI reported. | Other | MRI |
| RadiographyAlso: Diagnostic Imaging: Conventional radiography.Biannual disease progression monitoring with radiography of both hands and wrists. Scored using the van der Heijde-modified Sharp score. Radiography intervention group also undergoes MRI imaging. Only protocol determined smallest detectable changes on radiography reported. | Other | Radiography |
| Standard of CareAlso: Placebo control: see MRI and radiography interventions.Diagnostic imaging results (MRI or radiography) reported upon requisition. Standard of Care intervention group undergoes both MRI and radiography imaging. Upon requisition of either MRI or radiography, radiology reports are delivered as per institutional standard of care | Other | Standard of Care |
Primary outcome
The frequency of antirheumatic treatment escalations.
Time frame: Two years
9 secondary outcomes
Change in van der Heijde-modified Sharp score of the hands and feet.
Time frame: Two years
Change in 28-joint disease activity score (DAS28)
Time frame: Two years
Change in health assessment questionnaire (HAQ) score
Time frame: Two years
Change in Xie-modified rheumatoid arthritis magnetic resonance imaging score (RAMRIS)
Time frame: Two years
Change in health utility index - mark 3 (HUI-III)
Time frame: Two years
Change in EQ-5D
Time frame: Two years
Number of smallest detectable changes
Time frame: Two years
Change in the proportion of participants with radiography-determined erosions of the hands, wrists, or feet
Time frame: Two years
Change in the number of radiography-determined erosions of the hands, wrists or feet
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Background: PubMed 18821687Brown AK, Conaghan PG, Karim Z, Quinn MA, Ikeda K, Peterfy CG, Hensor E, Wakefield RJ, O'Connor PJ, Emery P. An explanation for the apparent dissociation between clinical remission and continued structural deterioration in rheumatoid arthritis. Arthritis Rheum. 2008 Oct;58(10):2958-67. doi: 10.1002/art.23945.
- Background: PubMed 17519063Schiff MH, Hobbs KF, Gensler T, Keenan GF. A retrospective analysis of low-field strength magnetic resonance imaging and the management of patients with rheumatoid arthritis. Curr Med Res Opin. 2007 May;23(5):961-8. doi: 10.1185/030079907x178892.
- Background: PubMed 10364913McQueen FM, Stewart N, Crabbe J, Robinson E, Yeoman S, Tan PL, McLean L. Magnetic resonance imaging of the wrist in early rheumatoid arthritis reveals progression of erosions despite clinical improvement. Ann Rheum Dis. 1999 Mar;58(3):156-63. doi: 10.1136/ard.58.3.156.
- Background: PubMed 18322995Olech E, Freeston JE, Conaghan PG, Hensor EM, Emery P, Yocum D. Using extremity magnetic resonance imaging to assess and monitor early rheumatoid arthritis: the optimal joint combination to be scanned in clinical practice. J Rheumatol. 2008 Apr;35(4):580-3. Epub 2008 Mar 1.
- Background: PubMed 19032820Xie X, Webber CE, Adachi JD, O'Neill J, Inglis D, Bobba RS, Wu H. Quantitative, small bore, 1 Tesla, magnetic resonance imaging of the hands of patients with rheumatoid arthritis. Clin Exp Rheumatol. 2008 Sep-Oct;26(5):860-5.
- Background: PubMed 2565997van der Heijde DM, van Riel PL, Nuver-Zwart IH, Gribnau FW, vad de Putte LB. Effects of hydroxychloroquine and sulphasalazine on progression of joint damage in rheumatoid arthritis. Lancet. 1989 May 13;1(8646):1036-8. doi: 10.1016/s0140-6736(89)92442-2.
- Background: PubMed 4597226Taves DR. Minimization: a new method of assigning patients to treatment and control groups. Clin Pharmacol Ther. 1974 May;15(5):443-53. doi: 10.1002/cpt1974155443. No abstract available.
- Background: PubMed 18512708Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, Paulus HE, Mudano A, Pisu M, Elkins-Melton M, Outman R, Allison JJ, Suarez Almazor M, Bridges SL Jr, Chatham WW, Hochberg M, MacLean C, Mikuls T, Moreland LW, O'Dell J, Turkiewicz AM, Furst DE; American College of Rheumatology. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008 Jun 15;59(6):762-84. doi: 10.1002/art.23721. No abstract available.
- Background: PubMed 11874828Emery P, Breedveld FC, Dougados M, Kalden JR, Schiff MH, Smolen JS. Early referral recommendation for newly diagnosed rheumatoid arthritis: evidence based development of a clinical guide. Ann Rheum Dis. 2002 Apr;61(4):290-7. doi: 10.1136/ard.61.4.290.
- Derived from this study: PubMed 24997587Tavares R, Beattie KA, Bensen WG, Bobba RS, Cividino AA, Finlay K, Goeree R, Hart LE, Jurriaans E, Larche MJ, Parasu N, Tarride JE, Webber CE, Adachi JD. A double-blind, randomized controlled trial to compare the effect of biannual peripheral magnetic resonance imaging, radiography and standard of care disease progression monitoring on pharmacotherapeutic escalation in rheumatoid and undifferentiated inflammatory arthritis: study protocol for a randomized controlled trial. Trials. 2014 Jul 5;15:268. doi: 10.1186/1745-6215-15-268.
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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.
Ruben Tavares, MBt MSc CCRA principal investigator
McMaster University
Jonathan D Adachi, MD FRCPC study chair
McMaster University
Maggie J Larche, MD PhD study director
McMaster University
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 MRI and Radiography in people with Inflammatory Arthritis, run by McMaster University at 1 site in Canada.
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 9 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: status not confirmed, as of the sponsor's last update on 7 Oct 2011. 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 Canada. 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. Some participants in this study may receive a placebo. 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?
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?
The frequency of antirheumatic treatment escalations. (time frame: Two 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 NCT00808496, which also lists 10 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 7 Oct 2011.