Trial · NCT01919164
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
NCT01919164, Phase 2, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2020-07-13
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ConductScience Library. A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee. Trials, record NCT01919164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01919164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
- NCT number
- NCT01919164
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 549 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Osteoarthritis, Knee
- Interventions
- Sprifermin, Placebo
- First posted
- 2013-08-08
- Last updated
- 2020-07-13
- Other registries' IDs
- eudract:2011-003059-20
- Results first posted
- 2020-07-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Baseline, Year 2 (Week 104) | The change in cartilage thickness at 2 years was calculated based on quantitative magnetic resonance imaging (qMRI). |
| Secondary | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Baseline, Week 52, Week 78 and Week 104 | WOMAC pain subscale consists of 5 questions (Likert Scale) relating to pain. Sum of items of pain subscale ranges from 0-11. Higher scores=worse pain. Stiffness subscale consists of 2 questions relating articular function. Sum of items of stiffness subscale ranges from 0-8. Higher scores=worse function. Physical function subscale consists of 17 question relating to physical activities. Sum of items of physical function subscale ranges from 0-68. Higher scores= worse functional limitations. Each sub-scale is directly transformed into a 0-100 scale, where higher score indicates worse condition. WOMAC total score(24questions) is sum of total subscales which was directly transformed into score range from 0-100. Higher scores=worse condition. Negative value in change is indicative of improvement. |
| Secondary | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | The 20-meter walk test is an objective test of physical function which consists of measuring the time needed for the participant to walk 20 meters at a normal pace. A stopwatch was used for time measurement. |
| Secondary | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | The Patient Global Assessment is based on participant's answer to the question "Considering all the ways your osteoarthritis of the knee has affected you during the last 48 Hours, select the number that best describes the impact of your knee osteoarthritis on your daily life", and can take on values between 0-10 (0=None, 10=Extreme), for summaries the values are rescaled to 0-100 by multiplication with 10. Higher scores indicated worsening of condition. A negative value in change in Patient's Global Assessment is indicative of an improvement. |
| Secondary | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Baseline, Week 52 and 104 | Change in joint space narrowing was visualized with the "fixed flexion" knee radiograph. Determination of joint space narrowing by X-ray is considered to be a semi-quantitative method for assessment of progression of knee Osteoarthritis (OA). X-rays of both the target knee and the contralateral knee were performed. X-rays were read centrally. X-ray images were used to measure mJSW in the medial femorotibial and lateral femorotibial compartments and to determine the participant's baseline Kellgren-Lawrence grades (KLG). |
| Secondary | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial and Lateral: Baseline, Week 26, 52, 78 and 104; Total: Baseline, Week 26, 52 and 78 | The change in cartilage thickness was calculated based on quantitative magnetic resonance imaging (qMRI). |
| Secondary | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Baseline, Week 26, 52, 78 and 104 | The change in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint at Week 26, 52, 78 and 104 was calculated based on qMRI. |
| Secondary | Synovial Fluid Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) | Levels of sprifermin/FGF-18 in synovial fluid were measured to provide a first estimate of the residence time of sprifermin in the synovial fluid. |
| Secondary | Serum Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Baseline, Year 2 (Week 104) | Modified intent to treat (ITT) analysis set included all randomized participants that is, only planned treatment regimen was used and who had a baseline, at least 1 post-treatment qMRI assessment available in double-blind placebo-controlled part. Here Number of Participants analyzed = participants evaluable for this outcome measure. | millimeters | MEAN |
| SECONDARY | Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Baseline, Week 52, Week 78 and Week 104 | Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in the 20-meter Walk Test at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints. | seconds | MEAN |
| SECONDARY | Change From Baseline in the Patient's Global Assessment (PGA) at Week 12, 26, 38, 52, 64, 78, 90 and 104 | Baseline, Week 12, 26, 38, 52, 64, 78, 90 and 104 | Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Minimal Joint Space Width (mJSW) in the Medial and Lateral Compartments as Evaluated by X-ray at Week 52 and 104 | Baseline, Week 52 and 104 | Intention-to-Treat (ITT) analysis set included all participants randomly allocated to a treatment, based on the intention to treat as randomized principle. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints. | millimeter | MEAN |
| SECONDARY | Change From Baseline in Cartilage Thickness in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint | Medial and Lateral: Baseline, Week 26, 52, 78 and 104; Total: Baseline, Week 26, 52 and 78 | Modified ITT analysis set was used. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints. | millimeter | MEAN |
| SECONDARY | Change From Baseline in Cartilage-Volume in the Medial and Lateral Compartments as Well as in the Total Femorotibial Joint at Week 26, 52, 78 and 104 | Baseline, Week 26, 52, 78 and 104 | Modified ITT analysis set was used. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed included those who were evaluable at specified timepoints. | microliter | MEAN |
| SECONDARY | Synovial Fluid Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) | Safety analysis set included all participants who received at least 1 dose of study treatment. Arm assignments for participants in Safety Set were based on actual treatment received. Here Number of Participants analyzed = participants evaluable for this outcome measure and Number analyzed are those who were evaluable at specified timepoint. | picogram/milliliter | MEDIAN |
| SECONDARY | Serum Levels of Sprifermin/FGF-18 | Pre-dose at Week 0, 2 hours post-dose at Week 1 and 2 of Cycle 1, 2, 3 and 4 (each cycle is of 28 days) | Safety analysis set included all participants who received at least 1 dose of study treatment. Arm assignments for participants in Safety Set were based on actual treatment received. | picogram/milliliter | MEAN |
Source ClinicalTrials.gov
Results by group330
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Placebo | -0.02 | Standard Deviation 0.07 | millimeters | |
| Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | -0.01 | Standard Deviation 0.07 | millimeters | |
| Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Sprifermin (AS902330) 30 mcg- 4 Cycles | 0.00 | Standard Deviation 0.07 | millimeters | |
| Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 0.02 | Standard Deviation 0.08 | millimeters | |
| Change From Baseline in Cartilage Thickness in the Total Femorotibial Joint as Evaluated by Quantitative Magnetic Resonance Imaging (qMRI) at Year 2 | Sprifermin (AS902330) 100 mcg- 4 Cycles | 0.03 | Standard Deviation 0.07 | millimeters | |
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Placebo | Pain: Change at Week 52 | -18.51 | Standard Deviation 19.49 | score on a scale |
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | Pain: Change at Week 52 | -21.55 | Standard Deviation 18.36 | score on a scale |
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Sprifermin (AS902330) 30 mcg- 4 Cycles | Pain: Change at Week 52 | -15.40 | Standard Deviation 18.31 | score on a scale |
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | Pain: Change at Week 52 | -21.12 | Standard Deviation 19.73 | score on a scale |
Changes From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale, Stiffness Subscale, Physical Function Subscale and Total Score at Week 52, Week 78 and Week 104 | Sprifermin (AS902330) 100 mcg- 4 Cycles | Pain: Change at Week 52 | -23.34 | Standard Deviation 17.92 | score on a scale |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 108 | |
| Overall Study | STARTED | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | 110 | |
| Overall Study | STARTED | Sprifermin (AS902330) 30 mcg- 4 Cycles | 111 | |
| Overall Study | STARTED | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 110 | |
| Overall Study | STARTED | Sprifermin (AS902330) 100 mcg- 4 Cycles | 110 | |
| Overall Study | Safety Analysis Set | Placebo | 107 | |
| Overall Study | Safety Analysis Set | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | 109 | |
| Overall Study | Safety Analysis Set | Sprifermin (AS902330) 30 mcg- 4 Cycles | 111 | |
| Overall Study | Safety Analysis Set | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 111 | |
| Overall Study | Safety Analysis Set | Sprifermin (AS902330) 100 mcg- 4 Cycles | 109 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events1,095
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypothyroidism | Endocrine disorders | Placebo | 2 | 107 | |
| other | Hypothyroidism | Endocrine disorders | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | 1 | 109 | |
| other | Hypothyroidism | Endocrine disorders | Sprifermin (AS902330) 30 mcg- 4 Cycles | 1 | 111 | |
| other | Hypothyroidism | Endocrine disorders | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 6 | 111 | |
| other | Hypothyroidism | Endocrine disorders | Sprifermin (AS902330) 100 mcg- 4 Cycles | 2 | 109 | |
| other | Cataract | Eye disorders | Placebo | 8 | 107 | |
| other | Cataract | Eye disorders | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | 6 | 109 | |
| other | Cataract | Eye disorders | Sprifermin (AS902330) 30 mcg- 4 Cycles | 10 | 111 | |
| other | Cataract | Eye disorders | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 6 | 111 | |
| other | Cataract | Eye disorders | Sprifermin (AS902330) 100 mcg- 4 Cycles | 4 | 109 |
1 to 10 of 1,095Source ClinicalTrials.gov
See all 1,095 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 1 | 107 |
| Total, all-cause mortality | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | 0 | 109 |
| Total, all-cause mortality | Sprifermin (AS902330) 30 mcg- 4 Cycles | 0 | 111 |
| Total, all-cause mortality | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 0 | 111 |
| Total, all-cause mortality | Sprifermin (AS902330) 100 mcg- 4 Cycles | 0 | 109 |
| Total, other adverse events | Placebo | 105 | 107 |
| Total, other adverse events | Sprifermin (AS902330) 30 mcg/Placebo - 2 Cycles | 106 | 109 |
| Total, other adverse events | Sprifermin (AS902330) 30 mcg- 4 Cycles | 109 | 111 |
| Total, other adverse events | Sprifermin (AS902330) 100 mcg/Placebo (2 Cycles) | 106 | 111 |
| Total, other adverse events | Sprifermin (AS902330) 100 mcg- 4 Cycles | 107 | 109 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01919164
GET https://conductscience.org/api/trials/v1/NCT01919164/results?page=2