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

Study Description

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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 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 or disease	Intervention/treatment	Phase
Arthritis, Rheumatoid	Drug: FANG(30); Drug: Placebo	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	October 2006
Actual Primary Completion Date :	January 2008
Actual Study Completion Date :	February 2008

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1 - FANG(30); 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; 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: Placebo; Placebo 30mg tabs, 3/day, 105 days continuously.; Other Name: FARMINDUSTRIA Specific Placebo tabs/Lot FANG06 & 01-ANDRO-07

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

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Locations

Chile
HOSPITAL REGIONAL de OSORNO
Osorno, Los Lagos, Chile, 5290000
Hospital Clínico Regional
Valdivia, Los Ríos, Chile, 5090000

Sponsors and Collaborators

Juan C. Bertoglio, MD

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

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Additional Information:

Government of Chile - Science and Technology Development Fund (Study main sponsor) 

Publications of Results:

Burgos RA, Hancke JL, Bertoglio JC, Aguirre V, Arriagada S, Calvo M, Cáceres DD. Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial. Clin Rheumatol. 2009 Aug;28(8):931-46. doi: 10.1007/s10067-009-1180-5. Epub 2009 Apr 29.

Other Publications:

Agrawal S, Kandimalla ER. Antisense and/or immunostimulatory oligonucleotide therapeutics. Curr Cancer Drug Targets. 2001 Nov;1(3):197-209. Review.

Clark W, Jobanputra P, Barton P, Burls A. The clinical and cost-effectiveness of anakinra for the treatment of rheumatoid arthritis in adults: a systematic review and economic analysis. Health Technol Assess. 2004 May;8(18):iii-iv, ix-x, 1-105. Review.

FitzGerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med. 2001 Aug 9;345(6):433-42. Review.

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.

Hengge UR, Brockmeyer NH, Goos M. Granulocyte colony-stimulating factor treatment in AIDS patients. Clin Investig. 1992 Oct;70(10):922-6.

Iruretagoyena MI, Tobar JA, González PA, Sepúlveda SE, Figueroa CA, Burgos RA, Hancke JL, Kalergis AM. Andrographolide interferes with T cell activation and reduces experimental autoimmune encephalomyelitis in the mouse. J Pharmacol Exp Ther. 2005 Jan;312(1):366-72. Epub 2004 Aug 26.

Olsen NJ, Stein CM. New drugs for rheumatoid arthritis. N Engl J Med. 2004 May 20;350(21):2167-79. Review.

Setoguchi K, Misaki Y, Terauchi Y, Yamauchi T, Kawahata K, Kadowaki T, Yamamoto K. Peroxisome proliferator-activated receptor-gamma haploinsufficiency enhances B cell proliferative responses and exacerbates experimentally induced arthritis. J Clin Invest. 2001 Dec;108(11):1667-75.

Smolen JS, Steiner G. Therapeutic strategies for rheumatoid arthritis. Nat Rev Drug Discov. 2003 Jun;2(6):473-88. Review.

Topol EJ. Failing the public health--rofecoxib, Merck, and the FDA. N Engl J Med. 2004 Oct 21;351(17):1707-9. Epub 2004 Oct 6.

Yamamoto Y, Gaynor RB. Therapeutic potential of inhibition of the NF-kappaB pathway in the treatment of inflammation and cancer. J Clin Invest. 2001 Jan;107(2):135-42. Review.

Yazici Y, Erkan D, Paget SA. Monitoring by rheumatologists for methotrexate-, etanercept-, infliximab-, and anakinra-associated adverse events. Arthritis Rheum. 2003 Oct;48(10):2769-72.

Yazici Y, Erkan D, Paget SA. Monitoring methotrexate hepatic toxicity in rheumatoid arthritis: is it time to update the guidelines? J Rheumatol. 2002 Aug;29(8):1586-9. Review.

Responsible Party:	Juan C. Bertoglio, MD, Principal Investigator, Universidad Austral de Chile
ClinicalTrials.gov Identifier:	NCT00749645 History of Changes
Other Study ID Numbers:	PCT06-AG-02; DO4I1240FONDEF ( Other Identifier: CHILE Scientific Technological Development Fund )
First Posted:	September 9, 2008
Last Update Posted:	June 23, 2016
Last Verified:	October 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	All these data has been accepted for publication in Clinical Rheumatology

Keywords provided by Juan C. Bertoglio, MD, 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; 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