Clinical Trial Results:
Controlled randomized study on maintenance to low activity disease with low doses of SKA citokines compared with standard therapy (DMARDS)of arthritis management
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Summary
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EudraCT number |
2011-003016-23 |
Trial protocol |
IT |
Global end of trial date |
27 Feb 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jan 2025
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First version publication date |
08 Jan 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CIDAI
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
GUNA S.p.a.
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Sponsor organisation address |
Via Palmanova, 71, Milan, Italy, 20132
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Public contact |
Segreteria ANTIAGE, ANTIAGE onlus, 39 0633585802, albertomigliore@terra.es
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Scientific contact |
Vincenzo Miranda, GUNA S.p.a., 39 0228018358, v.miranda@guna.it
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Feb 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Estimating that the proportion of patients who maintain the remission after the therapy of active branch is greater than or equal respect of patients in control branch.
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Protection of trial subjects |
The use of celecoxib 200mg has been predicted as a pain killer in case of need.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 39
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Worldwide total number of subjects |
39
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EEA total number of subjects |
39
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
39
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were enrolled at the Rheumatology Unit, San Pietro Hospital Fatebenefratelli, Rome, between July 2011 and March 2014. A total of 52 subjects were screened and 39 were enrolled and randomized as shown in the clinical trial flow diagram. In detail, five males and 34 females (mean age: 55.19) with RA, diagnosed according to ACR criteria, were | |||||||||
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Pre-assignment
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Screening details |
INCLUSION CRITERIA • RA diagnosed according to ACR criteria • Duration of disease <3 years • Disease activity of 28 joints [DAS28] <3.2 after Biologic and/or DMARD therapy • Patients who have reached the state of remission or LDA after treatment with Biologic or after one therapy with DMARDs • Patients able to adhere to the procedures of the s | |||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group A | |||||||||
Arm description |
An active arm consisting of patients who had achieved a low level of activity or remission of the disease after biological therapy or conventional therapy with DMARDs (MTX, CyA, Leflunomide) who were treated with Guna-Anti IL1, Guna-Interleukin4, Guna-Interleukin10 formulated in a concentration of 10 fg/ml at a dose of 20 drops/day. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Guna-Anti IL1
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral drops, liquid
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Routes of administration |
Buccal use
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Dosage and administration details |
20 drops/day.
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Arm title
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Group B | |||||||||
Arm description |
A control arm made up of patients who had achieved a low level of activity or remission of the disease after biological therapy or conventional therapy with DMARDs (MTX, CyA, Leflunomide) who were treated with traditional therapy alone (MTX, Steroids and NSAIDs) | |||||||||
Arm type |
conventional therapy | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Group A
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Reporting group description |
An active arm consisting of patients who had achieved a low level of activity or remission of the disease after biological therapy or conventional therapy with DMARDs (MTX, CyA, Leflunomide) who were treated with Guna-Anti IL1, Guna-Interleukin4, Guna-Interleukin10 formulated in a concentration of 10 fg/ml at a dose of 20 drops/day. | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group B
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Reporting group description |
A control arm made up of patients who had achieved a low level of activity or remission of the disease after biological therapy or conventional therapy with DMARDs (MTX, CyA, Leflunomide) who were treated with traditional therapy alone (MTX, Steroids and NSAIDs) | ||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group A
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Reporting group description |
An active arm consisting of patients who had achieved a low level of activity or remission of the disease after biological therapy or conventional therapy with DMARDs (MTX, CyA, Leflunomide) who were treated with Guna-Anti IL1, Guna-Interleukin4, Guna-Interleukin10 formulated in a concentration of 10 fg/ml at a dose of 20 drops/day. | ||
Reporting group title |
Group B
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Reporting group description |
A control arm made up of patients who had achieved a low level of activity or remission of the disease after biological therapy or conventional therapy with DMARDs (MTX, CyA, Leflunomide) who were treated with traditional therapy alone (MTX, Steroids and NSAIDs) | ||
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End point title |
Evaluate for how long the association of Guna-Anti IL 1, Guna-Interleukin 4, Guna-Interleukin 10, at low doses of 1fg/ml can maintain the low disease activity obtained after DMARDs or "Biologicals" in patients suffering from RA compared to treatment with [1] | ||||||||||||
End point description |
The rate of maintenance of LDA at 12 months was superior in the group treated with low-dose cytokines compared with patients treated with DMARDs, 66.7% and 42.1%, respectively; however, the difference between the groups was not statistically significant.
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End point type |
Primary
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End point timeframe |
From T0 to T12 month
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: A descriptive analysis was performed for all the demographic variables and clinical features at baseline. Student’s t-test for paired data was conducted to evaluate the clinical efficacy parameters (DAS28) of treatment at 12 months, compared to baseline. In case of violation of the assumptions underlying the aforementioned parametric statistical tests, the analysis was performed with a nonparametric method, in particular, the Wilcoxon test. The McNemar test was used in each group of patients to |
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
from T0 to T12
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Adverse event reporting additional description |
Adverse events are monitored daily and possibly recorded via e-CRF
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Assessment type |
Systematic | |||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
Group A
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Reporting group description |
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Reporting group title |
Group B
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: A total of 34 patients were exposed to treatments during 12 months. Respectively, 15 subjects in Group A, composed of patients who achieved an LDA or remission of the disease after biological therapy or conventional therapy with DMARDs, were treated with Guna-IL-4, Guna-IL-10, and Guna-Anti-IL-1 formulated concentration 10 fg/mL, and 19 patients in the Group B, who similarly achieved an LDA or remission of the disease after biological therapy or conventional therapy with DMARDs, were treated wit |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| The results obtained do not reach the primary endpoint. It is important to underline that these results cannot be considered definitive as they emerged from an insufficiently representative sample and consequently (powerless than 80% due to the low n | |||
