E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Pain due to osteoarthritis of the knee or hip |
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E.1.1.1 | Medical condition in easily understood language |
Pain of the knee or hip due to a joint disease that results from breakdown of joint cartilage and underlying bone |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020108 |
E.1.2 | Term | Hips osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip. |
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E.2.2 | Secondary objectives of the trial |
•To assess the use of paracetamol/acetaminophen for the fasinumab arms compared to placebo from baseline to week 16 •To assess the use of paracetamol/acetaminophen for the fasinumab arms compared to placebo from baseline to week 52 •To assess the use of standard of care analgesic medication, including NSAIDs, for non OA pain in patients randomized to fasinumab compared to placebo from week 16 through the end of treatment •To assess time to JR
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Efficacy Sub study Primary objective To evaluate the efficacy of fasinumab compared with placebo when administered to patients with pain due to radiographically-confirmed OA of the knee or hip.
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E.3 | Principal inclusion criteria |
1) Male or female > 18 years of age at the screening visit 2) Clinical diagnosis of OA of knee or hip based on ACR criteria with radiologic evidence of OA and moderate to severe pain in an eligible joint defined by WOMAC pain subscore 3) Willing to discontinue current pain medication 4) A history of 12 weeks of analgesic use for OA of the knee or hip as defined by: - Inadequate pain relief from paracetamol/acetaminophen, and - Intolerance or inadequate pain relief from at least 1 oral NSAID, and - Intolerance to or inadequate pain relief from opioid therapy, unwillingness to take opioid therapy for a medically acceptable reason, or lack of access to opioid therapy 5) History of regular use of analgesic medications for OA pain Additional Inclusion Criteria for Sub-study Patients 1) Willing to discontinue glucosamine sulphate and chondroitin sulphate treatments during the initial 16 weeks of treatment. 2) Stable treatment with glucosamine sulphate and chondroitine sulphate treatments must be stopped during the pre-randomization period. |
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E.4 | Principal exclusion criteria |
1) Joint diseases or other underlying conditions that can confound with the study parameters 2) Recent use of systemic or intra-articular corticosteroids 3) Evidence of destructive arthropathy 4) Evidence of autonomic or other neuropathy 5) Scheduled for joint replacement surgery during the trial 6) Other medical conditions that may interfere with participation or accurate assessments during the trial 7) Member of the clinical site study team and/or his/her immediate family 8) Pregnant or breastfeeding women |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint in the study is safety monitoring including AE incidence, SAE incidence, AESI incidence, changes in safety laboratory analyses, and incidence of anti fasinumab antibody formation from baseline to week 52 (treatment period 1 and 2) and to week 72 (end of follow-up period). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Other exploratory endpoints in the study are: •The proportion of patients taking rescue medication, number of days on rescue medication, and weekly average usage of rescue medication •The percent of patients using standard-of-care analgesic medication •Time to JR decision •Survey of Autonomic Symptom scores
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability Efficacy only for the Onset of Pain Relief Sub-study |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Czech Republic |
Denmark |
Estonia |
France |
Germany |
Hong Kong |
Hungary |
Italy |
Lithuania |
Mexico |
Peru |
Poland |
Romania |
Russian Federation |
South Africa |
Spain |
Sweden |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the study is defined as the end of study telephone contact for the last patient. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 11 |