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

This study has been completed.
Sponsor:
Collaborator:
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Information provided by:
Universidad Austral de Chile
ClinicalTrials.gov Identifier:
NCT00749645
First received: September 7, 2008
Last updated: September 10, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: FANG(30)
Drug: Specific Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult Patients

Resource links provided by NLM:


Further study details as provided by Universidad Austral de Chile:

Primary Outcome Measures:
  • Primary: Day1, end of week2, then every 4 weeks for 105 days, the following will be measured: 1.Inflamed and painful joints count. 2. Intensity of pain by patient on Visual Analogue Scale(VAS). 3. Overall improvement by HAQ and SF 36 (enclosed). [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary:Day1, end of week2, then every 4 weeks for 3 mo, it will be measured: Morning stiffness duration. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Symptoms relief by patient and researcher. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Paracetamol used as rescue medicine for pain. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
  • Tolerability by patient and researcher. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2006
Study Completion Date: February 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Active comparator, consisted of 30 adult patients with active Rheumatoid Arthritis, randomly assigned, taking the active product, in addition to base medication (Mtx + Pdn)
Drug: FANG(30)
Andrographolide formula Oral tablets, 30mg, three times per day, during a total of 105 continuous days.
Other Name: FANG 30mg tablets, FARMINDUSTRIA, Lots FANG06 & 01-ANDRO-07
Placebo Comparator: 2
Placebo comparator, consisted of 30 adult patients with active Rheumatoid Arthritis, randomly assigned, taking the placebo formulation, in addition to base medication (Mtx + Pdn)
Drug: Specific Placebo
Specific Placebo 30mg tabs, 3/day, 105 days continuously.
Other Name: FARMINDUSTRIA Specific Placebo tabs/Lot FANG06 & 01-ANDRO-07

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749645

Locations
Chile
HOSPITAL REGIONAL de OSORNO
Osorno, Los Lagos, Chile, 5290000
Hospital Clínico Regional
Valdivia, Chile, 5090000
Sponsors and Collaborators
Universidad Austral de Chile
Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Investigators
Study Chair: Juan L. Hancke, DVM, PhD Universidad Austral de Chile
Study Director: Rafael A. Burgos, DVM, MSc Universidad Austral de Chile
Principal Investigator: Juan C. Bertoglio, MD Universidad Austral de Chile
  More Information

Additional Information:
Publications:
Hidalgo, M. A., Romero, A., Figueroa, J., Cortés, P., Concha, I. I. Hancke, J. L. &. Burgos, R. A. Andrographolide interferes with binding of nuclear factor-kB (NF-kB) to DNA in HL-60-derived neutrophilic cells. British Journal of Pharmacology 2004. Jan; 141(2): 311-21.
Olsen, N.J. & Stein, C.M. (2004). New Drugs for Rheumatoid Arthritis. N Engl J Med, 350, 2167-2179.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Name / Official Title: Rafael A. Burgos / Project Director., Universidad Austral de Chile, Instituto de Farmacología
ClinicalTrials.gov Identifier: NCT00749645     History of Changes
Other Study ID Numbers: PCT06-AG-02, FONDEF DO4I1240(RA)
Study First Received: September 7, 2008
Last Updated: September 10, 2008
Health Authority: Chile: Instituto de Salud Pública de Chile

Keywords provided by Universidad Austral de Chile:
Arthritis, Rheumatoid, Andrographolides treatment, Efficacy.

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Andrographolide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors
Hematologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014