Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Dietary Supplement: Oncoxin + Viusid; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00969527

CAT-0903-CU

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Oncoxin + Viusid

Treatment:

Dietary Supplement: Oncoxin + Viusid

B

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo