Rheumatoid ArthritisPhase 4MuscaraNCT01609205
Doppler Evaluation in RA Patients After Adalimumab.
A Phase 4 study testing Adalimumab in people with Rheumatoid Arthritis, run by Hamed Rezaei at 2 sites in Sweden.
Trial summary
The purpose is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSweden
- Study dates
- Oct 2012to Sep 2017
- 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
- Adult patient (> 18 years of age), male or female
- Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
- Moderate to high disease activity
- Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
- Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
- Signed Informed Consent *Signed Informed Consent must be obtained before any study specific procedures take place.
Who cannot join
- Biologic treatment with Adalimumab before inclusion
- Two or more ongoing biologic treatments before inclusion
- Treatment with other biologic treatment than anti-TNF therapy before inclusion
- Any contraindication for treatment with Adalimumab
- Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
- Positive for tuberculosis or hepatitis B.
- Ongoing pregnancy or lactation
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Linköping University Hospital
Linköping
The karolinska Institute
Stockholm, 171 76
About this study
Official title: Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With Adalimumab
The purpose is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Adalimumab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called Humira
Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Adalimumab Receives: Biological: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of different clinical (EULAR) response
The primary endpoint will be the proportion of different clinical (EULAR) response (good, moderate, no response)* to add-on therapy with anti-TNF treatment at 6 months follow-up visit in patients with activity versus in those without activity measured by Doppler ultrasound at baseline.
Measured: 6 months from BL
Secondary outcomes (1)
The proportion of patients with good response to add-on therapy
The proportion of patients with good response to add-on therapy (measured by both Doppler and clinical assessment) at 6 and 12 months follow-up visits in two groups of patients, those who achieve low disease activity according to Doppler assessment at 3 months visit versus those who did not.
Measured: 6 and 12 months from BL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2017
- Study completionSep 2017
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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamed Rezaei
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor-investigator, Hamed Rezaei, Karolinska Institutet
- Investigators
- Monica Rydén Aulin, Phd, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609205
- Sponsor's protocol ID
- ClinTrid-US-1201
- Other IDs
- 2012-002573-62
- Acronym
- Muscara
- Status last verified
- Apr 2018
- First submitted
- 29 May 2012
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Doppler Quantitative Evaluation and Follow-up Over 12 Months in RA Patients With Moderate and High Disease Activity Who Are Candidates for Biologic add-on Therapy With Adalimumab
- ClinicalTrials.gov ID
- NCT01609205
- Acronym / sponsor ID
- Muscara / ClinTrid-US-1201
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hamed RezaeiUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Oct 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 31 May 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 is to study the relationship between RA disease activity based on Doppler quantification and the subsequent clinical response (EULAR response) to treatment with Adalimumab during 12 months. The purpose is also to compare the Doppler quantification with conventional clinical methods and semiquantitative Doppler assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: AdalimumabAdalimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patient (> 18 years of age), male or female
- Rheumatoid arthritis according to the 1987 ACR or 2010 EULAR/ACR classification criteria
- Moderate to high disease activity
- Ongoing anti-rheumatic treatment with DMARD, with stable dosage during the last 3 months, and being a candidate for anti-TNF add-on therapy OR ongoing treatment with first anti-TNF therapy and being a candidate for switch to another anti-TNF therapy
- Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
Key exclusion criteria (7 listed)
- Biologic treatment with Adalimumab before inclusion
- Two or more ongoing biologic treatments before inclusion
- Treatment with other biologic treatment than anti-TNF therapy before inclusion
- Any contraindication for treatment with Adalimumab
- Intraarticular corticosteroid injection during the last 4 weeks before each follow-up visit
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 |
|---|---|---|
| AdalimumabAlso: HumiraAdalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD | Biological | Arm 1 |
Primary outcome
The proportion of different clinical (EULAR) response
Time frame: 6 months from BL
The primary endpoint will be the proportion of different clinical (EULAR) response (good, moderate, no response)* to add-on therapy with anti-TNF treatment at 6 months follow-up visit in patients with activity versus in those without activity measured by Doppler ultrasound at baseline.
1 secondary outcome
The proportion of patients with good response to add-on therapy
Time frame: 6 and 12 months from BL
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 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
Active, not recruitingObservational study
Neuropathic Hand Pain in Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach
Arthritis, Rheumatoid, Ultrasound
Recruiting
EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))
Osteoarthritis, Traumatic Arthritis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingObservational study
The Impact of Rheumatoid Arthritis Treatments on the Modulation of Extracellular Vesicles and Other Biomarkers Involved in the Development of Lung Cancer
Rheumatoid Arthritis (RA), Lung Neoplasms
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.
Monica Rydén Aulin, Phd study chair
Karolinska Institutet
2 sites 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 in people with Rheumatoid Arthritis, run by Hamed Rezaei at 2 sites in Sweden.
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 7 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 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
The proportion of different clinical (EULAR) response (time frame: 6 months from BL). 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 25 Apr 2018; AzTrials last refreshed its copy on 5 Nov 2026.