Rheumatoid ArthritisPhase 3NCT00969527
Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
A Phase 3 study testing Oncoxin + Viusid in people with Rheumatoid Arthritis, run by Catalysis SL at 1 site in Cuba.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Oncoxin + Viusid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteCuba
- Study dates
- Sep 2009to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment-naive subjects with recent onset rheumatoid arthritis
- Signed informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Efficacy of Oncoxin+Viusid Administration 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Oncoxin + Viusid, Placebo
- Keywords
- Oncoxin, Viusid, dietary supplements, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncoxin + ViusidDietary supplement
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
PlaceboDietary supplement
50 ml of Placebo (orally administered) twice a day, for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oncoxin + Viusid Receives: Dietary Supplement: Oncoxin + Viusid |
| B | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 weeks
Secondary outcomes (1)
Number of patients with Adverse Events at week 12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catalysis SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Juan Carlos Delgado Morales, MD, Principal investigator, "Fructuoso Rodríguez" Orthopedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969527
- Sponsor's protocol ID
- CAT-0903-CU
- Status last verified
- May 2011
- First submitted
- 27 Aug 2009
- Last updated
- 9 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00969527
- Acronym / sponsor ID
- CAT-0903-CU
- Conditions
- Rheumatoid Arthritis
- Keywords
- Oncoxin, Viusid, dietary supplements, rheumatoid arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Catalysis SLIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Oncoxin + ViusidOncoxin + Viusid |
| B | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treatment-naive subjects with recent onset rheumatoid arthritis
- Signed informed consent
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncoxin + Viusid50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks. | Dietary supplement | A |
| Placebo50 ml of Placebo (orally administered) twice a day, for 12 weeks. | Dietary supplement | B |
Primary outcome
Disease Activity Score (DAS 28 score) at week 12.
Time frame: 12 weeks
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)
1 secondary outcome
Number of patients with Adverse Events at week 12
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Carlos Delgado Morales, MD principal investigator
"Fructuoso Rodríguez" Orthopedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oncoxin + Viusid in people with Rheumatoid Arthritis, run by Catalysis SL at 1 site in Cuba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cuba. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Score (DAS 28 score) at week 12. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2011.