Inflammatory Diseases, Polymyalgia Rheumatica
Conditions
Keywords
Polymyalgia Rheumatica, Inflammatory Disease, Rheumatic Disease
Brief summary
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinational study. The protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1. Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.
Interventions
DRUGPlacebo
Matching placebo to AIN457, ACZ885 and prednisone
DRUGAIN457
3 mg/kg
DRUGACZ885
3 mg/kg
DRUGPrednisone
20 mg
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following features: * Patients ≥ 50 and ≤ 85 years * C-reactive protein (CRP) \> 1.0 mg/dl OR erythrocyte sedimentation rate (ESR) \> 30 mm/hr * New bilateral shoulder and/or hip pain * Early morning stiffness ≥ 60 min * Duration of illness \> 1 week * A negative 5 U purified protein derivative skin test (PPD) skin test (≤ 5 mm induration) at screening
Exclusion criteria
* Active infection or current use of antibiotics * Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatits B virus (HBV) * Previous therapy with methotrexate or other immunosuppressive agents within three months prior to baseline * History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix within five years prior to study entry * Presence of rheumatoid arthritis or other inflammatory arthritic processes (features of Giant Cell Artertitis (GCA), spondyloarthropathies), connective tissue disease, drug-induced myopathies, endocrine disorders, neurological disorders, chronic pain syndromes, as assessed by base line screening including thyroid-stimulating hormone (TSH), creatine kinase (CK), rheumatoid factor (RF), cyclic citrullinated peptide (CCP), antinuclear antibodies (ANA), serum protein electrophoresis, urinalysis. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polymyalgia Rheumatica Activity Score (PMR-AS) | Baseline, Day 15 | The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Clinical Response | Day 15 | The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: \>70% reduction in patient global assessment VAS compared with baseline, morning stiffness \< 30 min, CRP \< 1.0 mg/dL and/or ESR \< 30 mm/1st hr. |
| Time to First Flare | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44 |
| Number of Flares Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. |
| Mean Steroid Dose Over a 6 Month Period | 6 months | This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure. |
| Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | 6 months | — |
| Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885 - Assessed by the Number of Flares After Redosing. | 6 months | One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm. |
| Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | 6 months | The Short Form-36 (SF-36) Questionnaire is a 36-item questionnaire yields an 8-scale health profile as well as summary measures of individual patients.. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health. |
| Time to Partial Clinical Response | Day 15 | The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had: \>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness \< 60 minutes. |
| Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6 | 6 months | HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability. |
| Pharmacokinetics of AIN457 and ACZ885 - Cmax | Day 15 | — |
| Pharmacokinetics of AIN457 and ACZ885 - Tmax | Day 15 | — |
| Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast | Day 15 | — |
| Pharmacokinetics of AIN457 and ACZ885 - CL | Day 15 | — |
| Pharmacokinetics of AIN457 and ACZ885 - Vz | Day 15 | — |
| Pharmacokinetics of AIN457 and ACZ885 - T1/2 | Day 15 | — |
| Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | baseline and at month 6 | HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability. |
Countries
Germany, Italy, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACZ885 On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering. | 5 |
| AIN457 On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering. | 6 |
| Prednisone On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study. | 5 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems | 1 | 0 | 0 |
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Protocol deviation | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | ACZ885 | AIN457 | Prednisone | Total |
|---|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 9.09 | 68.8 years STANDARD_DEVIATION 8.61 | 69.4 years STANDARD_DEVIATION 7.89 | 68.5 years STANDARD_DEVIATION 8.02 |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 3 / 5 | 2 / 6 | 5 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Polymyalgia Rheumatica Activity Score (PMR-AS)
The efficacy of a single dose of AIN457 and ACZ885 (canakinumab) was measured by the polymyalgia rheumatica activity score. A composite PMR-AS was developed from the following components: measure of C-reactive protein (CRP), measure of Erythrocyte Sedimentation Rate (ESR), assessment of early morning stiffness, assessment of the patient's elevation on upper limbs, patient's assessment of pain, and physician's global assessment of disease activity. Treatment effect was measured by the percent reduction in PMR-AS. N=3 for the ACZ885 arm because CRP values at Day 15 were missing for 2 participants.
Time frame: Baseline, Day 15
Population: Pharmacodynamic (PD) Analysis Set: This set included participants who received at least one dose of study medication and had no major protocol deviation that may impact the PD data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Polymyalgia Rheumatica Activity Score (PMR-AS) | 64.5 Percent reduction | Standard Error 0.68 |
| AIN457 | Polymyalgia Rheumatica Activity Score (PMR-AS) | 51.7 Percent reduction | Standard Error 0.47 |
| Prednisone | Polymyalgia Rheumatica Activity Score (PMR-AS) | 91.9 Percent reduction | Standard Error 86.2 |
Secondary
Comparison Between the Initial Response to AIN457 and ACZ885 and the Response After Re-dosing of AIN457 and ACZ885 - Assessed by the Number of Flares After Redosing.
One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm.
Time frame: 6 months
Population: One participant experienced one flare after initial dose but this participant had no flare after a redose. This patient was in the AIN457 arm.
Secondary
Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ)
HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability.
Time frame: baseline and at month 6
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACZ885 | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | standard disability score at baseline | 1.900 Scores on a scale | Standard Deviation 0.6869 |
| ACZ885 | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | standard disability score at EOS / Month 6 (n=4,6,3) | 0.719 Scores on a scale | Standard Deviation 1.0225 |
| AIN457 | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | standard disability score at baseline | 1.646 Scores on a scale | Standard Deviation 0.2896 |
| AIN457 | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | standard disability score at EOS / Month 6 (n=4,6,3) | 0.188 Scores on a scale | Standard Deviation 0.3513 |
| Prednisone | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | standard disability score at baseline | 2.063 Scores on a scale | Standard Deviation 0.2394 |
| Prednisone | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) | standard disability score at EOS / Month 6 (n=4,6,3) | 0.958 Scores on a scale | Standard Deviation 0.3819 |
Secondary
Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6
HAQ: The scores range from 0 (min) to 3 (max). Higher scores = more disability; lower scores = less disability.
Time frame: 6 months
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6 | -68.06 Percentage | Standard Deviation 36.781 |
| AIN457 | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6 | -86.83 Percentage | Standard Deviation 25.478 |
| Prednisone | Effect on Health-related Quality of Life Via the Health Assessment Questionnaire (HAQ) - % Change From Baseline in the Standard Disability Score at EOS / Month 6 | -54.04 Percentage | Standard Deviation 12.296 |
Secondary
Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire
The Short Form-36 (SF-36) Questionnaire is a 36-item questionnaire yields an 8-scale health profile as well as summary measures of individual patients.. The scores range for each subscale from 0 to 10, and the composite score ranges from 0 to 100, with higher scores indicative of better health.
Time frame: 6 months
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACZ885 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Physical component score at baseline | 26.126 Scores on a scale | Standard Deviation 8.1517 |
| ACZ885 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Physical component score at EOS / Month 6 (n=4,6,2) | 44.293 Scores on a scale | Standard Deviation 12.6038 |
| ACZ885 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Mental component score at baseline | 30.490 Scores on a scale | Standard Deviation 11.2875 |
| ACZ885 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Mental component score at month 6 / EOS (n=4,6,2) | 44.668 Scores on a scale | Standard Deviation 20.3716 |
| AIN457 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Mental component score at month 6 / EOS (n=4,6,2) | 54.136 Scores on a scale | Standard Deviation 8.8815 |
| AIN457 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Physical component score at baseline | 29.009 Scores on a scale | Standard Deviation 4.3115 |
| AIN457 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Mental component score at baseline | 35.779 Scores on a scale | Standard Deviation 5.9113 |
| AIN457 | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Physical component score at EOS / Month 6 (n=4,6,2) | 48.496 Scores on a scale | Standard Deviation 8.2306 |
| Prednisone | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Mental component score at month 6 / EOS (n=4,6,2) | 55.233 Scores on a scale | Standard Deviation 2.8274 |
| Prednisone | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Physical component score at EOS / Month 6 (n=4,6,2) | 34.544 Scores on a scale | Standard Deviation 7.7632 |
| Prednisone | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Mental component score at baseline | 29.673 Scores on a scale | Standard Deviation 6.1925 |
| Prednisone | Effect on Health-related Quality of Life Via the Short Form-36 (SF-36) Questionnaire | Physical component score at baseline | 27.001 Scores on a scale | Standard Deviation 5.2561 |
Secondary
Mean Steroid Dose Over a 6 Month Period
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Time frame: 6 months
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Mean Steroid Dose Over a 6 Month Period | 276.8 Number of doses | Standard Deviation 46.34 |
| AIN457 | Mean Steroid Dose Over a 6 Month Period | 256.7 Number of doses | Standard Deviation 27.89 |
| Prednisone | Mean Steroid Dose Over a 6 Month Period | 428.9 Number of doses | Standard Deviation 131.44 |
Secondary
Number of Flares Over a 6 Month Period
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
Time frame: 6 months
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 | Number of Flares Over a 6 Month Period | 1 Participant |
Secondary
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths
Time frame: 6 months
Population: Safety analysis set: This set included all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACZ885 | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Serious Adverse Events | 0 Participants |
| ACZ885 | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Adverse Events (serious and non-serious) | 3 Participants |
| ACZ885 | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Deaths | 0 Participants |
| AIN457 | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Serious Adverse Events | 0 Participants |
| AIN457 | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Adverse Events (serious and non-serious) | 2 Participants |
| AIN457 | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Deaths | 0 Participants |
| Prednisone | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Adverse Events (serious and non-serious) | 5 Participants |
| Prednisone | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Deaths | 0 Participants |
| Prednisone | Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths | Serious Adverse Events | 0 Participants |
Secondary
Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast
Time frame: Day 15
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast | AUCinf (microg/day/mL) | 1570 microg/day/mL | Standard Deviation 80 |
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast | AUClast (microg/day/mL) | 1560 microg/day/mL | Standard Deviation 74.7 |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast | AUCinf (microg/day/mL) | 1260 microg/day/mL | Standard Deviation 134 |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast | AUClast (microg/day/mL) | 1200 microg/day/mL | Standard Deviation 132 |
Secondary
Pharmacokinetics of AIN457 and ACZ885 - CL
Time frame: Day 15
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - CL | 0.171 L/day | Standard Deviation 0.44 |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - CL | 0.157 L/day | Standard Deviation 0.0106 |
Secondary
Pharmacokinetics of AIN457 and ACZ885 - Cmax
Time frame: Day 15
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurement for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - Cmax | 69.9 microgram/mL | Standard Deviation 5.58 |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - Cmax | 46.8 microgram/mL | Standard Deviation 2.85 |
Secondary
Pharmacokinetics of AIN457 and ACZ885 - T1/2
Time frame: Day 15
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - T1/2 | 26.6 Day | Standard Deviation 2.38 |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - T1/2 | 40.2 Day | Standard Deviation 4.47 |
Secondary
Pharmacokinetics of AIN457 and ACZ885 - Tmax
Time frame: Day 15
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurement for the outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - Tmax | 0.0868 days |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - Tmax | 0.107 days |
Secondary
Pharmacokinetics of AIN457 and ACZ885 - Vz
Time frame: Day 15
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. The summary statistics include patients with a valid measurements for the outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACZ885 | Pharmacokinetics of AIN457 and ACZ885 - Vz | 6.49 L | Standard Deviation 1.19 |
| AIN457 | Pharmacokinetics of AIN457 and ACZ885 - Vz | 9.85 L | Standard Deviation 1.29 |
Secondary
Time to Complete Clinical Response
The time to complete clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a complete clinical response at Day 15. A participant was defined as a complete responder if the participant had: \>70% reduction in patient global assessment VAS compared with baseline, morning stiffness \< 30 min, CRP \< 1.0 mg/dL and/or ESR \< 30 mm/1st hr.
Time frame: Day 15
Population: PD analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACZ885 | Time to Complete Clinical Response | 0.0 Percentage of participants |
| AIN457 | Time to Complete Clinical Response | 0.0 Percentage of participants |
| Prednisone | Time to Complete Clinical Response | 25.0 Percentage of participants |
Secondary
Time to First Flare
This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44
Time frame: 6 months
Population: This study was terminated because the data did not show that the two biologic treatments impacted PMR disease activity to the same degree as steroid treatment within a 2-week treatment period. Only 1 participant experienced a flare, in the AIN457 treatment group. The flare for this one participant occurred on study day 44
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AIN457 | Time to First Flare | 44 Days |
Secondary
Time to Partial Clinical Response
The time to partial clinical response was assessed in patients who received a single dose of AIN457 or ACZ885 (canakinumab). Daily monitoring (home-based) of CRP was performed. This outcome shows the percentage of patients who achieved a partial clinical response at Day 15. A participant was defined as a partial responder if the participant had: \>50% reduction in patient global assessment visual analogue scale (VAS) compared with baseline and morning stiffness \< 60 minutes.
Time frame: Day 15
Population: PD analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACZ885 | Time to Partial Clinical Response | 20.0 Percentage of participants |
| AIN457 | Time to Partial Clinical Response | 16.7 Percentage of participants |
| Prednisone | Time to Partial Clinical Response | 75.0 Percentage of participants |