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

NCT00749645 | Completed Phase 2 DMC

• 2 other identifiers: PCT06-AG-02DO4I1240FONDEF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthritis, Rheumatoid

Keywords

Arthritis, Rheumatoid, Andrographolides treatment, Efficacy.

Outcome Measures

Primary Outcomes (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).

  Monthly

Secondary Outcomes (4)

• Secondary:Day1, end of week2, then every 4 weeks for 3 mo, it will be measured: Morning stiffness duration.

  Monthly

• Symptoms relief by patient and researcher.

  Monthly

• Paracetamol used as rescue medicine for pain.

  Monthly

• Tolerability by patient and researcher.

  Monthly

Study Arms (2)

1 - FANG(30)

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)

2 - Placebo

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: Placebo

Interventions

FANG(30) DRUG

Andrographolide formula Oral tablets, 30mg, three times per day, during a total of 105 continuous days.

Also known as: FANG 30mg tablets, FARMINDUSTRIA, Lots FANG06 & 01-ANDRO-07

1 - FANG(30)

Placebo DRUG

Placebo 30mg tabs, 3/day, 105 days continuously.

Also known as: FARMINDUSTRIA Specific Placebo tabs/Lot FANG06 & 01-ANDRO-07

2 - Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juan C. Bertoglio, MD: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (2)

HOSPITAL REGIONAL de OSORNO

Osorno, Los Lagos Region, 5290000, Chile

Location

Hospital Clínico Regional

Valdivia, Los Ríos Region, 5090000, Chile

Location

Related Publications (14)

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• Hidalgo MA, Romero A, Figueroa J, Cortes P, Concha II, Hancke JL, Burgos RA. Andrographolide interferes with binding of nuclear factor-kappaB to DNA in HL-60-derived neutrophilic cells. Br J Pharmacol. 2005 Mar;144(5):680-6. doi: 10.1038/sj.bjp.0706105.

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  PMID: 12180713 BACKGROUND

• Burgos RA, Hancke JL, Bertoglio JC, Aguirre V, Arriagada S, Calvo M, Caceres 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.

  PMID: 19408036 RESULT

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Tablets

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Juan L. Hancke, DVM, PhD

  Universidad Austral de Chile

  STUDY CHAIR

• Rafael A. Burgos, DVM, MSc

  Universidad Austral de Chile

  STUDY DIRECTOR

• Juan C. Bertoglio, MD

  Universidad Austral de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2008
• First Posted: September 9, 2008
• Study Start: October 1, 2006
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 23, 2016

Record last verified: 2014-10

Data Sharing

• IPD Sharing: Will share

Locations

CL (2)