Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-24 @ 4:53 PM
NCT ID:
NCT01643850
Eligibility Criteria:
Inclusion criteria:
* Males and Females aged ≥ 18 years (≥ 12 years in PART C) with PVNS or GCTTS with, at least, one measurable site of disease on MRI.
* Patients expected to get surgery (PART A of study only).
* Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.
* Patients with normal level of serum ionized calcium and phosphate.
* Women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion.
Exclusion criteria:
* Patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy.
* Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
* Use previously of intra-articular treatment within 4 weeks prior dosing.
* Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
* Patients with elevated troponin T and/or CK levels (\> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
* Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
* Patients engaged in a resistance exercise training program.
* Patients with pacemakers or any metallic objects as exclusion for MRI
* Patients with concomitant disease know to get influence on bone metabolism
* Patients who have history of drug or alcohol abuse within 12 months prior study dosing.
* Pregnant or nursing (lactating) women.
Other protocol-defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01643850
Study Brief:
Protocol Section:
NCT01643850