Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis
1 other identifier
interventional
86
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Sep 2009
Shorter than P25 for phase_3 rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2009
CompletedFirst Posted
Study publicly available on registry
September 1, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 9, 2011
May 1, 2011
1.5 years
August 27, 2009
May 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Activity Score (DAS 28 score) at week 12.
DAS 28=(0.56√NAD+ 0.28√NAT+0.7lnVSG+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
Secondary Outcomes (1)
Number of patients with Adverse Events at week 12
12 weeks
Study Arms (2)
A
EXPERIMENTALOncoxin + Viusid
B
PLACEBO COMPARATORInterventions
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
Eligibility Criteria
You may qualify if:
- Treatment-naive subjects with recent onset rheumatoid arthritis
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catalysis SLlead
Study Sites (1)
Fructuoso Rodriguez Orthopedic Hospital
Havana, 10400, Cuba
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan Carlos Delgado Morales, MD
"Fructuoso Rodríguez" Orthopedic Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 27, 2009
First Posted
September 1, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
April 1, 2011
Last Updated
May 9, 2011
Record last verified: 2011-05