Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969527
• Other study ID #: CAT-0903-CU
• Status: Completed
• Phase: Phase 3
• First received: August 27, 2009
• Last updated: May 6, 2011
• Start date: September 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Oncoxin + Viusid
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
• Placebo
50 ml of Placebo (orally administered) twice a day, for 12 weeks.

Locations

Country	Name	City	State
Cuba	Fructuoso Rodriguez Orthopedic Hospital	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score (DAS 28 score) at week 12.	DAS 28=(0.56vNAD+ 0.28vNAT+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)	12 weeks	No
Secondary	Number of patients with Adverse Events at week 12		12 weeks	Yes