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 | 19.0 |
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 | 19.0 |
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 |
To describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed osteoarthritis (OA) of the knee or hip between baseline and week 16 (treatment period 1). |
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E.2.2 | Secondary objectives of the trial |
To describe the safety and tolerability of fasinumab, including AESIs, in patients with pain due to radiographically-confirmed OA of the knee or hip between:
- week 16 and week 52 (treatment period 2).
- baseline and week 52 (overall study period). |
|
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 objectives
To evaluate the efficacy of fasinumab compared to placebo as measured by:
- Change from baseline at week 16 in the Western Ontario and mcMaster Osteoarthritis Index (WOMAC) pain subscale score
- Change from baseline at week 16 in the WOMAC physical function subscale score
- Change from baseline at week 16 in the Patient Global Assessment of OA score
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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) History of inadequate pain relief or intolerance to analgesics used for OA
5) History of regular use of analgesic medications for OA
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 chondroitin 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) Pregnant or breastfeeding women |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety monitoring including adverse event (AE) incidence, serious adverse event (SAE) incidence, AESI incidence, changes
in safety laboratory analyses, and incidence of anti-fasinumab antibody formation between baseline and week 16 (treatment period 1). |
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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) |
- Safety monitoring through all adverse events incidences
- Incidence of anti-fasinumab antibody formation |
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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 | 2 |
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 | 5 |
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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LVLS - study ends after 24 weeks of follow up |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |