Aiming for Remission in Rheumatoid Arthritis (RA) - the ARCTIC Trial

NCT01205854

Last updated date
Study Location
Martina Hansens Hospital AS
Sandvika, Bærum, 1306, Norway
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

(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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

(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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Advanced Information
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
  • No Intervention: Conventional clinical and laboratory assessment
  • Experimental: Conventional assessment plus ultrasonography
    Intervention: Device: Ultrasonography
Publications *

*   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
 (submitted: April 15, 2015)
238
Original Estimated Enrollment  ICMJE
 (submitted: September 20, 2010)
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):

  • 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

Exclusion Criteria (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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • The Research Council of Norway
  • Smerud Medical Research International AS
  • Oslo University Hospital
  • Innovest
  • Abbott
  • UCB Nordic A/S
  • Pfizer
  • MSD Norway AS
  • Roche Pharma AG
  • The Norwegian Rheumatism Association
Investigators  ICMJE
Study Director:Tore K Kvien, MD, PhDDiakonhjemmet Hospital AS
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