Status:
COMPLETED
Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients
Lead Sponsor:
Juan C. Bertoglio, MD
Collaborating Sponsors:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a Clinical Pilot Phase II interventional, double blind, randomized and placebo controlled study to document the efficacy, tolerability and safety of FANG(30) in 60 adult patients affected with...
Detailed Description
Introduction: Rheumatoid Arthritis (RA) is a common rheumatic disease characterized by pain, inflammation and reduction in joint function. Hands and feet are the most commonly affected joints and pain...
Eligibility Criteria
Inclusion
- Patients, between 18 and 70 years of age.
- Clinical diagnosis of RA, based on typical history and clinical presentation of the patient according to the diagnostic criteria of the American College of Rheumatology (ACR), 1987.
- Active AR characterized by pain and increase in joint volume, in at least 1 joint, associated to VHS \> 20 mm/h and/or PCR \> 0,6 ng/ml.
- Ambulatory patient requiring treatment with anti-inflammatory drugs, whom is neither receiving non-steroidal anti-inflammatory drugs (NSAIDs) nor any other drugs, except Paracetamol, for at least 4 weeks previous to the beginning of the study.
- Also, patients with RA treated with Prednisone and/or Chloroquine and Methotrexate in stable doses for at least 6 weeks, with active arthritis, and willing to participate in the study.
- Willing to come to regular controls.
- Written consent signed by the patient, according to the criteria and text approved by the local Scientific Ethical Committee.
Exclusion
- Pregnant women, breast feeding, childbirth, potentially fertile and / or not following adequate contraceptive methods.
- Non degenerative joint diseases or other joint diseases that could interfere with the evaluation of RA (i.e. Gout, Pseudogout, Chondrocalcinosis, Psoriatic Arthritis, Infectious Arthritis, Reactive Arthritis or Spondylitic Arthritis).
- Severe disabling arthritis leaving the patient eligible for surgical intervention, or incapacitated and prostrated patients.
- Treatment with intra-joint injection with corticosteroids one month before treatment.
- Ongoing treatment with anticoagulants, hydantoins or lithium.
- Presence or history of digestive hemorrhage, peptic ulcer in the 6 previous months or hemorrhagic ulcer any time during the past, gall bladder stones or dysfunction.
- Hypersensitivity and / or intolerant to NSAIDs, including patients with bronchospam history induced by Aspirin.
- Evidence of renal, hepatic and severe hematopoietic diseases, and heart failure revealed by laboratory tests or other tests.
- History of using any other test drug, one month before to the beginning of this trial.
- Patients with tranquilizers, hypnotic or excess of alcohol, which can interfere with the perception of pain.
- Necessity of any other therapy for arthrosis, except Paracetamol used as a rescue drug during the period of study. Also exercise and/or physiotherapy, if ongoing, can continue without modification.
- Not willing to come for regular follow ups during the period of duration of the study.
- Non cooperative attitude.
- Any condition that in the opinion of the physician, does not justify the inclusion of the patient in the study.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00749645
Start Date
October 1 2006
End Date
February 1 2008
Last Update
June 23 2016
Active Locations (2)
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1
HOSPITAL REGIONAL de OSORNO
Osorno, Los Lagos Region, Chile, 5290000
2
Hospital Clínico Regional
Valdivia, Los Ríos Region, Chile, 5090000