Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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 active Rheumatoid Arthritis. Also, to evaluate the effect of an andrographolide natural formula, identified as FANG(30) or "the study product", on the immunological functions that influence chronic inflammatory process in these patients, who could benefit with this treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan C. Bertoglio, MD
• Collaborator: Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
• Treatments: Andrographolide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.