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Completed

NCT Number: NCT00969527

Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fructuoso Rodriguez Orthopedic Hospital

Havana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment-naive subjects with recent onset rheumatoid arthritis
  • Signed informed consent

Exclusion criteria

  • Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset
  • Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis

Treatment and study plan

Oncoxin + Viusid

Dietary Supplement

50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.

Placebo

Dietary Supplement

50 ml of Placebo (orally administered) twice a day, for 12 weeks.

Primary outcomes

  1. Disease Activity Score (DAS 28 score) at week 12.

    Time frame: 12 weeks

    DAS 28=(0.56√NAD+ 0.28√NAT+0.7ln⁡VSG+0.14EGE) where NAD: number of joints with pain; NAT: number of joints with increased volume; VSG: sedimentation rate of erythrocytes; EGE: Global assessment of disease by the patient on a visual analog scale (1 to 100 mm)

Secondary outcomes

  1. Number of patients with Adverse Events at week 12

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2009
Registry last updated
May 9, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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