Clinical Trial Results:
The effect of tofacitinib on the activity of JAK-STAT pathways in patients with rheumatoid arthritis (RA)
Summary
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EudraCT number |
2017-002753-11 |
Trial protocol |
FI |
Global end of trial date |
14 May 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
18 May 2022
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First version publication date |
18 May 2022
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Other versions |
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 |
TofaSTAT17
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Tampere University Hospital
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Sponsor organisation address |
PO Box 2000, Tampere, Finland, 33521
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Public contact |
Centre for Rheumatology, Tampere University Hospital, pia.isomaki@tuni.fi
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Scientific contact |
Centre for Rheumatology, Tampere University Hospital, pia.isomaki@tuni.fi
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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 |
11 Jan 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 May 2020
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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 |
Which JAK-STAT pathways are significantly inhibited by tofacitinib in vivo?
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Protection of trial subjects |
No specific measures
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Background therapy |
Ongoing treatment with conventional systemic disease-modyfying anti-rheumatic drugs with or without prednisolone up to 10 mg per day | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
29 May 2018
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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 |
Finland: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
18
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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) |
13
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From 65 to 84 years |
5
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85 years and over |
0
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Recruitment
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Recruitment details |
Adult RA patients who are treated with tofacitinib and give their written informed consent, are recruited to the study. Patients need to have active disease (DAS28 > 3.2) despite treatment with methotrexate and other traditional disease-modifying anti-rheumatic drugs. | ||||||||||
Pre-assignment
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Screening details |
Inclusion criteria: RA patient with active RA (DAS28 >3.2) despite treatment with methotrexate and other synthetic disease-modifying anti-rheumatic drugs No prior biologic or JAK inhibitor treatment Stable synthetic DMARD and prednisolone (0-10 mg/day) treatment allowed Patient has no contra-indications to tofacitinib treatment | ||||||||||
Period 1
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Period 1 title |
Study treatment (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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Tofacitinib | ||||||||||
Arm description |
All patients were treated with tofacitinib 5 mg BID | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Tofacitinib citrate
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Investigational medicinal product code |
PR1
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Totacitinib 5 mg tablet twice daily
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Baseline characteristics reporting groups
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Reporting group title |
Study treatment
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Reporting group description |
Includes the whole patient population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tofacitinib
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Reporting group description |
All patients were treated with tofacitinib 5 mg BID |
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End point title |
DAS28 remission [1] | ||||||||
End point description |
The study protocol included aims of the study, but no primary or secondary endpoints were named for this trial in the study protocol. For the purpose of filling in this part of the report, a disease activity measure DAS28 remission is reported here as a primary endpoint.
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End point type |
Primary
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End point timeframe |
DAS28 remission was determined at 3-mo visit
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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: Please see additional information on the page. No primary end points were defined in the protocol of this study. |
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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 |
Serious adverse events were reported from screening visit (0-3 mo before baseline visit) until a follow-up phone call which occurred 28 days after 3-mo visit
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Assessment type |
Non-systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
21.1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
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: For this phase IV study only serious adverse events were collected. Tofacitinib treatment was used as part of normal clinical care, and there was no control arm. Active treatment period was only 3 months. No serious adverse events were recorded during the study. |
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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. | |||
None reported |