Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01364389
Other study ID # CPJMR0012201
Secondary ID 2010-019395-73
Status Terminated
Phase Phase 2
First received
Last updated
Start date February 14, 2011
Est. completion date January 29, 2013

Study information

Verified date August 2021
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 16
Est. completion date January 29, 2013
Est. primary completion date January 29, 2013
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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/exclusion criteria apply

Study Design


Intervention

Drug:
AIN457
3 mg/kg
ACZ885
3 mg/kg
Prednisone
20 mg
Placebo
Matching placebo to AIN457, ACZ885 and prednisone

Locations

Country Name City State
Germany Novartis Investigative Site Berlin
Italy Novartis Investigative Site Reggio Emilia RE
Italy Novartis Investigative Site Siena SI
United Kingdom Novartis Investigative Site Basildon Essex
United Kingdom Novartis Investigative Site Westcliff-on-Sea Essex
United States Novartis Investigative Site Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Germany,  Italy,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
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. Baseline, Day 15
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.
Day 15
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. Day 15
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 6 months
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. 6 months
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. 6 months
Secondary Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Deaths 6 months
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. 6 months
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. 6 months
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. baseline and at month 6
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. 6 months
Secondary Pharmacokinetics of AIN457 and ACZ885 - Cmax Day 15
Secondary Pharmacokinetics of AIN457 and ACZ885 - Tmax Day 15
Secondary Pharmacokinetics of AIN457 and ACZ885 - AUCinf and AUClast Day 15
Secondary Pharmacokinetics of AIN457 and ACZ885 - CL Day 15
Secondary Pharmacokinetics of AIN457 and ACZ885 - Vz Day 15
Secondary Pharmacokinetics of AIN457 and ACZ885 - T1/2 Day 15
See also
  Status Clinical Trial Phase
Terminated NCT04972968 - A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154 Phase 2
Active, not recruiting NCT04519580 - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Recruiting NCT06460142 - Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
Terminated NCT03600818 - Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica Phase 3
Completed NCT00836810 - Timed Release Tablet Prednisone in Polymyalgia Rheumatica Phase 2/Phase 3
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Completed NCT03263715 - A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE) Phase 3
Recruiting NCT05935709 - DANIsh VASculitis Database (DANIVAS)
Not yet recruiting NCT02985424 - Polymyalgia Rheumatica and Giant Cell Arteritis N/A
Completed NCT00138983 - Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol. Phase 3
Recruiting NCT06130540 - Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR Phase 1
Recruiting NCT05767034 - Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR) Phase 3
Terminated NCT01821040 - A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR Phase 3
Recruiting NCT00982332 - Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica N/A
Recruiting NCT05312944 - Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome
Recruiting NCT04664465 - PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Withdrawn NCT02899026 - Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica Phase 3
Recruiting NCT03576794 - Treatment With Leflunomide in Patients With Polymyalgia Rheumatica Phase 3
Completed NCT05681676 - Melanocortin Gene Expression in Lymphocytes of Polymyalgia Patients
Recruiting NCT05435781 - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency Phase 4