Clinical Trial Results:
Prospective, Single-centre, Double-Blind, Randomised, Placebo-controlled Study Evaluating Efficacy of Adalimumab + Methotrextate Compared with Placebo + Methotrexate in Patients with Early Oligoarthritis
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Summary
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EudraCT number |
2008-004877-17 |
Trial protocol |
GB |
Global end of trial date |
16 Jan 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Aug 2020
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First version publication date |
07 Aug 2020
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Other versions |
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Summary report(s) |
ADEOS End of Trial report 8-10-18 |
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 |
RR08/8685
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Leeds
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Sponsor organisation address |
Woodhouse Lane, Leeds, United Kingdom, LS2 9JT
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Public contact |
Dr Ai Lyn Tan, University of Leeds, 0113 3924884, A.L.Tan@leeds.ac.uk
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Scientific contact |
Dr Ai Lyn Tan, University of Leeds, 0113 3924884, A.L.Tan@leeds.ac.uk
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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 |
16 Jan 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Jan 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
16 Jan 2017
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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 |
To assess the proportion of patients who achieve clinical remission after 24 weeks of adalimumab and methotrexate (MTX) therapy compared to methotrexate monotherapy in the management of early, persistent oligoarthritis. The defining criteria for clinical remission is absence of tender/swollen joints & CRP< 5mg/ml)
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Protection of trial subjects |
Before being enrolled in the clinical study, subjects must consent to participate after the
nature, scope, and possible consequences of the clinical study have been explained in
a form understandable to them.
An informed consent document that includes both information about the study and the
consent form will be prepared and given to the subject. This document will contain all
the elements required by ICH E6 Guideline for Good Clinical Practice and any additional
elements required by local regulations. The document must be in a language
understandable to the subject and must specify who informed the subject. Where
required by local law, the person who informs the subject must be a physician.
One copy of the informed consent document will be kept in the patient’s medical notes.
Further, a signed copy will be given to the patient.
The patient will be given at least 24 hours to consider this information after initially
receiving the patient information before the consent is taken. This process will be
documented in the patient notes. After reading the informed consent document, the
subject must give consent in writing. The subject's consent must be confirmed at the
time of consent by the personally dated signature of the subject and by the personally
dated signature of the person conducting the informed consent discussions.
A copy of the signed consent document must be given to the subject. The original
signed consent document will be retained by the investigator.
The investigator will not undertake any measures specifically required only for the
clinical study until valid consent has been obtained.
The investigator must inform the subject’s primary physician about the subject’s
participation in the trial if the subject has a primary physician and if the subject agrees to
the primary physician being informed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Dec 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 |
United Kingdom: 99999
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Worldwide total number of subjects |
99999
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EEA total number of subjects |
99999
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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) |
99999
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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 presenting at the rheumatology clinic who meet all of the screening criteria will be considered for enrolment into the study.A verbal explanation of the trial and Patient Information Sheet will be provided by the attending medical staff for the patient to consider. | |||||||||
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Pre-assignment
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Screening details |
Assenting patients will then be formally assessed for eligibility and invited to provide informed, written consent.The written consent will be taken by a clinician with the appropriate skills and training to do so, who has signed and dated the staff authorisation/delegation log. The process of obtaining written consent will be clearly documented | |||||||||
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Period 1
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Period 1 title |
Main Trial Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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adalimumab and methotrexate (MTX) combination therapy | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Adalimumab
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
40mg 2-weekly
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Investigational medicinal product name |
Methotrexate (with folic acid combination therapy)
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Investigational medicinal product code |
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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 |
25mg weekly
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Arm title
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methotrextate monotherapy | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Methotrexate (with folic acid combination therapy)
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Investigational medicinal product code |
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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 |
25mg weekly
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Baseline characteristics reporting groups
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Reporting group title |
Main Trial Period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
adalimumab and methotrexate (MTX) combination therapy
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Reporting group description |
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Reporting group title |
methotrextate monotherapy
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Reporting group description |
- | ||
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End point title |
Number of patients in clinical remission at week 24 [1] | |||||||||
End point description |
number of patients in clinical remission at week 24 (defined as
absence of tender/swollen joints & CRP < 5mg/L)
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End point type |
Primary
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End point timeframe |
screening- week 24
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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 full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required. |
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| Notes [2] - data analysis is incomplete for this trial. [3] - data analysis is incomplete for this trial. |
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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 |
SAE's were assessed at every study visit, and were reported within the regulatory guidelines
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4
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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: A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted. It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Jan 2017 |
The trial had multiple substantial amendments, but a full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication for this trial and results analysis was halted.
It was agreed with the MHRA in September 2019 that a full data upload on EudraCT is not required. |
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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. | |||
| A full data set to satisfy the requirements for the EudraCT upload is unavailable as the data analysis is incomplete for this trial. Following discussion with the UK regulator the MHRA its was agreed that the trial teams would not pursue publication | |||
