Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT01067430 |
| Other study ID # |
IISP 35166 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
April 2010 |
| Est. completion date |
April 2011 |
Study information
| Verified date |
June 2021 |
| Source |
Northumbria Healthcare NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to explore the effect of Etoricoxib compared to Diclofenac on
physical activity in RA subjects with early morning pain and stiffness.
Description:
Rheumatoid Arhthitis (RA) is a chronic inflammatory condition characterised by prolonged
morning stiffness. Anti-inflammatory medication is effective in relieving the pain and
stiffness associated with this inflammation. By having a long half-life, Etoricoxib has a
simple once daily dosing regime and the long action overnight should mean that patients
experience more effective relief of symptoms first thing in the morning compared to shorter
half life medication such as Diclofenac. The activity of people can be measured using the
NuMact monitor which has been validated against observation and for use in RA . As the data
is logged in real time it is possible to extract the periods of activity at the start of the
day when morning stiffness will be maximal. It counts the number and vigour of steps.
This can be used to give a measure of total ambulatory activity but in this instance we are
interested primarily in the vigour of step first thing in the morning. The vigour of the
steps (trunk deceleration on heel strike) is a measure of how easily and quickly a subject is
walking. We would expect this to be markedly reduced in people with RA during their period of
"morning stiffness".
This is a study is of a randomised crossover design. The aim is to recruit 20 subjects
suffering from Rheumatoid Arthritis. 20 has been chosen as a suitable number to show the
effects of the two drugs and allow design of a definitive study. All participants will be
tolerant of conventional NSAIDs.
All subjects will be given patient information sheets at least 24 hours before the first
visit. They will be allowed time to read the information sheet and given the opportunity to
ask further questions if they wish during the pre-baseline week.
The first visit is the baseline visit during which informed consent will be taken by the
Chief Investigator, all of the inclusion and exclusion criteria will be checked to ensure the
subject still meets the criteria. A history of NSAID use will also be taken to ensure subject
tolerance of the drug. Quality of life Questionnaires will be administered during this visit,
they will consist of the:
Health Assessment Questionnaire (HAQ) which assesses dressing, arising, eating, walking,
hygiene, reach, grip and common activities. For each of these categories, patients report the
amount of difficulty they have in performing two or three specific activities. There are 4
possible responses; without ANY difficulty; with SOME difficulty; with MUCH difficulty;
UNABLE to do.
Pain VAS and Fatigue VAS The visual analog scale (VAS fatigue) is a horizontal line; 100 mm
in length, self-administered by the patient in order to rate pain from 0 "no fatigue" to 100
"worst possible fatigue".
DAS28 is a measure of disease activity in rheumatoid arthritis (RA). The score is calculated
by a mathematical formula, which includes the number of tender and swollen joints (out of a
total of 28), the erythrocyte sedimentation rate (ESR, a blood marker of inflammation). A
DAS28 score greater than 5.1 implies active disease, less than 3.2 well controlled disease,
and less than 2.6 remission.
A physical examination by the Chief Investigator will also take place at this visit and
concomitant medication and any adverse events occurring since receiving the patient
information leaflet will be recorded.
Assessments will be done at baseline and after 2 weeks of treatment with each
anti-inflammatory. At the baseline visit subjects will have a 48 hr run-in period where they
will be allocated placebo. During this time a 24 hr recording using the NuMact Ambulatory
device wll be taken. This has been included so that treatment effect vs placebo can be
recorded which would strengthen the final analysis and findings. The NuMact ambulatory
activity monitor will be used to assess spontaneous ambulatory activity.
After the 48 hr period the first arm of the study will commence and subjects will be randomly
allocated to receive either Etoricoxib 90 mg once a day or Diclofenac 50 mg three times a
day, which will be prescribed for 2 weeks. At the end of this period (visit 3), a further
NuMact reading will take place and disease status will be assessed using the DAS 28, HAQ VAS
Pain and VAS Fatigue. A home visit will take place to remove the NuMact device with the
patient's consent. This has been written into the protocol because a second reading could
take place should the reading fail at visit 3. At visit 5 the patient will return to the
hospital to start the second arm of treatment where they will cross over to either Etoricoxib
90 mg tonce a day or Diclofenac 50 mg three times a day. They will be prescribed this
medication for two weeks and at visit 6 another NuMact recording will take place and disease
status will be assessed using the DAS 28, HAQ VAS Pain and VAS Fatigue. With the patient's
consent, the device will be removed after 24 hrs at the patient's home.
Physical examination will be carried out at the baseline visit and at visits 3 and 6. It
could be carried out at any time during the study period if considered appropriate by the
physician.
Concomitant medication and therapy and adverse events will be recorded by the Investigator at
each study visit.
A follow-up phone call will be undertaken 2 weeks after the final visit as a safety measure.
