Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients (FANG30-RA)

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.