Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial
NCT01205854
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
(all):
- Male or non-pregnant, non-nursing female
- > 18 years of age and < 75 years of age
- Patients classified as having RA (according to new ACR/EULAR criteria)
- Disease duration less than 2 years (defined as time from 1st joint swelling)
- The treating rheumatologist decides the patient requires treatment with a Disease Modifying Anti-Rheumatic Drug (DMARD)
- The patient has taken no prior DMARD
- Patients able and willing to give written informed consent and comply with the requirements of the study protocol
(any):
- Abnormal renal function (serum creatinine > 142 µmol/L in female and > 168 µmol/L in
male)
- Abnormal liver function, active or recent hepatitis, cirrhosis
- Major co-morbidities like severe malignancies, severe diabetic mellitus, severe
infections, uncontrollable hypertension, severe cardiovascular disease and/or severe
respiratory diseases.
- Leukopenia and/or thrombocytopenia
- Inadequate birth control conception, pregnancy, and/or breastfeeding
- Indications of active tuberculosis
- Psychiatric or mental disorders, alcohol abuse or other abuse of substances, language
barriers or other factors which makes adherence to the study protocol impossible
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial | |||
| Official Title ICMJE | Aiming for Remission in Rheumatoid Arthritis: a Randomized Trial Examining the Benefit of Ultrasonography in a Clinical TIght Control Regimen | |||
| Brief Summary | The ultimate goal of treatment in early rheumatoid arthritis (RA) is remission, i.e. an absence of signs and symptoms of the disease. However, the optimal way of reaching this goal is not known. Ultrasonography (US) is an imaging modality which application is rapidly growing. It has a number of advantages over other advanced imaging techniques such as magnetic resonance imaging (MRI), including low cost, good accessibility, and ability to scan many joints in a short period of time. However, the additional benefit of using this modality in terms of patient outcomes has not been demonstrated. Thus, clarification is needed if the use of US leads to better care for RA patients. This study will assess if the use of a treatment strategy incorporating information from ultrasonography assessment will allow for better outcomes of patients with RA, than a strategy based on clinical and laboratory assessments alone. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Rheumatoid Arthritis | |||
| Intervention ICMJE | Device: Ultrasonography
Standardized ultrasonographic assessment of 32 joints, assessed for both grey scale synovitis and power doppler signal, at each visit. Dose escalations based on DAS response in combination with change in US score. All joints with US Power Doppler signal are targets for intra articular injections. | |||
| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 238 | |||
| Original Estimated Enrollment ICMJE | 240 | |||
| Actual Study Completion Date ICMJE | April 2015 | |||
| Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion criteria (all):
Exclusion Criteria (any):
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Norway | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01205854 | |||
| Other Study ID Numbers ICMJE | DIA2010-1 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Espen A. Haavardsholm, Diakonhjemmet Hospital | |||
| Study Sponsor ICMJE | Espen A. Haavardsholm | |||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Diakonhjemmet Hospital | |||
| Verification Date | April 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||