Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment |
Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear. |
Samples collected about 30 minutes before first treatment injection and about five days after this first injection |
|
| Primary |
Initial degree of inflammation, as measured by a pathologist during histological assessment |
Samples will be sectioned and stained with Haemotoxylin and Eosin and a pathologist blind to treatment will examine the sections under a microscope to determine whether or not inflammation is present compared to how healthy samples would be expected to appear. |
Samples collected about five days after first injection of treatment |
|
| Secondary |
Initial disease activity as measured by blinded clinician using DAS28 (Disease Activity Score) |
In DAS28, a clinician assesses 28 specified joints for tenderness and swelling. A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h). The patient global health assessment (from 0=best to 100=worst) is also used. A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm. |
Assessments are performed about 1 hour before first treatment injection |
|
| Secondary |
Disease activity after short-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score) |
In DAS28, a clinician assesses 28 specified joints for tenderness and swelling. A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h). The patient global health assessment (from 0=best to 100=worst) is also used. A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm. |
Assessments are performed about 5 days after first treatment injection |
|
| Secondary |
Disease activity after long-term treatment as measured by blinded clinician using DAS28 (Disease Activity Score) |
In DAS28, a clinician assesses 28 specified joints for tenderness and swelling. A blood draw is performed at time of assessment to measure Erythrocyte Sedimentation Rate (in mm/h). The patient global health assessment (from 0=best to 100=worst) is also used. A specific algorithm is used to calculate the DAS28 score, using the measurements obtained as variables that plug into the algorithm. |
Assessments are performed about 5-6 weeks after first treatment injection. |
|
| Secondary |
Initial number of tender and swollen joints as measured by clinician while palpating 28 specified joints |
A clinician assesses 28 specified joints for tenderness and swelling. |
Assessments are performed about 1 hour before first treatment injection |
|
| Secondary |
Number of tender and swollen joints after short-term treatment as measured by clinician while palpating 28 specified joints |
A clinician assesses 28 specified joints for tenderness and swelling. |
Assessments are performed about 5 days after first treatment injection |
|
| Secondary |
Number of tender and swollen joints after long-term treatment as measured by clinician while palpating 28 specified joints |
A clinician assesses 28 specified joints for tenderness and swelling. |
Assessments are performed about 5-6 weeks after first treatment injection. |
|
| Secondary |
Initial Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) |
The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate. It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C. The blood is drawn into a Westergren-Katz tube to the 200 mm mark. The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured. The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate. |
Assessments are performed about 1 hour before first treatment injection |
|
| Secondary |
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after short-term treatment |
The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate. It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C. The blood is drawn into a Westergren-Katz tube to the 200 mm mark. The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured. The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate. |
Assessments are performed about 5 days after first treatment injection |
|
| Secondary |
Erythrocyte Sedimentation Rate (ESR) present in blood (in mm/h) after long-term treatment |
The Westergren method requires collecting 2 ml of venous blood into a tube containing 0 .5 ml of sodium citrate. It should be stored no longer than 2 hours at room temperature or 6 hours at 4 °C. The blood is drawn into a Westergren-Katz tube to the 200 mm mark. The tube is placed in a rack in a strictly vertical position for 1 hour at room temperature, at which time the distance from the lowest point of the surface meniscus to the upper limit of the red cell sediment is measured. The distance of fall of erythrocytes, expressed as millimeters in 1 hour, is the Erythrocyte Sedimentation Rate. |
Assessments are performed about 5-6 weeks after first treatment injection. |
|
| Secondary |
Initial patient global health assessment measured by the patient (from 0=best to 100=worst) |
A patient is asked to rate their general global health on a scale from 0 to 100 |
Assessments are performed about 1 hour before first treatment injection |
|
| Secondary |
Patient global health assessment measured by the patient (from 0=best to 100=worst) after short-term treatment |
A patient is asked to rate their general global health on a scale from 0 to 100 |
Assessments are performed about 5 days after first treatment injection |
|
| Secondary |
Patient global health assessment measured by the patient (from 0=best to 100=worst) after long-term treatment |
A patient is asked to rate their general global health on a scale from 0 to 100 |
Assessments are performed about 5-6 weeks after first treatment injection. |
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