Rheumatoid ArthritisNCT01029613
Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers
An observational study of Rheumatoid Arthritis, run by Glostrup University Hospital, Copenhagen at 8 sites in Denmark.
Trial summary
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Adalimumab
- How many people
- 40 participants
- Where
- 8 sitesDenmark
- Study dates
- Dec 2009to Jul 2013
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease activity starting TNF-alpha inhibitor
Who may be able to join
- Age > 18 years old and < 85 years old
- RA in accordance with American College of Rheumatology 1987 criteria
- Moderate or highly active RA defined as DAS28 > 3,2 (CRP based)
- Clinical indication for TNF-α inhibitor treatment by the treating physician
- No contraindications for TNF-α inhibitor treatment
- No contraindications for MRI
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- Serum creatinine in normal range
- Sufficient contraception for fertile women
- Capable of giving informed consent
- Capable of complying with the examination program of the protocol
Who cannot join
- Other DMARDs than MTX from less than 4 weeks before inclusion and throughout the study period
- Cyclophosphamide, Chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
- Intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
- Pregnancy wish, pregnancy or breast-feeding
- Contraindications for TNF-α inhibitor treatment
- Contraindications for MRI
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- Known recent drug or alcohol abuse
- Failure to provide written consent
- Incapable of complying with the examination program for physical or mental reasons
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Dep. of medicine, Herlev Hospital
Copenhagen
Dep. of Radiology, Herlev Hospital
Copenhagen
Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
Copenhagen
Dep. of Rheumatology, Gentofte Hospital
Copenhagen
Dep. of Rheumatology, Glostrup Hospital
Copenhagen
Dep. of Rheumatologym Glostrup Hospital
Copenhagen
Dep. of Rheumatology, Helsingør Hospital
Hørsholm
Dep. of Rheumatology, Køge Hospital
Køge
About this study
Official title: Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.
- 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.
AdalimumabDrug
sc. inj. Humira 40 mg every other week from week 0 to 52
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Not described Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
EULAR response criteria
Measured: 16 weeks
Secondary outcomes (3)
Number of joints with inflammation on MRI
Measured: 16 and 52 weeks
Erosions on X-rays and CT
Measured: 52 weeks
Biomarkers
Measured: 16 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2013
- Study completionJul 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOstergaard, Glostrup University Hospital, Copenhagen
- Investigators
- Mikkel Østergaard, Professor, Principal investigator, Dep. of Rheumatology, Glostrup HospitalSusanne J Pedersen, MD, Study chair, Dep. of Rheumatology, Glostrup Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029613
- Sponsor's protocol ID
- WRAP
- Status last verified
- Aug 2015
- First submitted
- 9 Dec 2009
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers
- ClinicalTrials.gov ID
- NCT01029613
- Acronym / sponsor ID
- WRAP
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Dec 2009 (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.
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | – | Drug: Adalimumab |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease activity starting TNF-alpha inhibitor
Key inclusion criteria (10 listed)
- Age > 18 years old and < 85 years old
- RA in accordance with American College of Rheumatology 1987 criteria
- Moderate or highly active RA defined as DAS28 > 3,2 (CRP based)
- Clinical indication for TNF-α inhibitor treatment by the treating physician
- No contraindications for TNF-α inhibitor treatment
Key exclusion criteria (9 listed)
- Other DMARDs than MTX from less than 4 weeks before inclusion and throughout the study period
- Cyclophosphamide, Chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
- Intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
- Pregnancy wish, pregnancy or breast-feeding
- Contraindications for TNF-α inhibitor 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 |
|---|---|---|
| Adalimumabsc. inj. Humira 40 mg every other week from week 0 to 52 | Drug | Rheumatoid arthritis |
Primary outcome
EULAR response criteria
Time frame: 16 weeks
3 secondary outcomes
Number of joints with inflammation on MRI
Time frame: 16 and 52 weeks
Erosions on X-rays and CT
Time frame: 52 weeks
Biomarkers
Time frame: 16 and 52 weeks
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 Aug 2015.
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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.
Mikkel Østergaard, Professor principal investigator
Dep. of Rheumatology, Glostrup Hospital
Susanne J Pedersen, MD study chair
Dep. of Rheumatology, Glostrup Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Glostrup University Hospital, Copenhagen at 8 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 10 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: finished, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
EULAR response criteria (time frame: 16 weeks). 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 19 Aug 2015.