Trial · NCT01969838
Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
NCT01969838, Phase 3, Completed, Sierra Oncology LLC - a GSK company; results first posted 2023-05-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis. Trials, record NCT01969838. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01969838
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis
- NCT number
- NCT01969838
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 432 participants, actual
- Lead sponsor
- Sierra Oncology LLC - a GSK company
- Conditions
- Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis
- Interventions
- Momelotinib, Ruxolitinib, Placebo to match momelotinib, Placebo to match ruxolitinib
- First posted
- 2013-10-25
- Last updated
- 2023-05-12
- Other registries' IDs
- eudract:2013-002707-33
- Results first posted
- 2023-05-12
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Splenic Response Rate at Week 24 | Week 24 | Splenic response rate at Week 24 is defined as the percentage of participants who achieved a spleen volume reduction of ≥ 35% from baseline at the Week 24 assessment as measured by MRI or CT. |
| Secondary | Total Symptom Score (TSS) Response Rate at Week 24 | Week 24 | Total symptom score (TSS) is defined as the percentage of participants who achieved a ≥50% reduction in TSS at Week 24 versus baseline as measured by the modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) v2.0 diary. Response rate was calculated using the average of the daily TSS from a consecutive 28-day period prior to Week 24, which had ≥20 daily TSS available. The modified MPN-SAF patient-reported outcome instrument consisted of 8 items assessing worst daily incidence of tiredness, filling up quickly, abdominal discomfort, night sweats, itching, bone pain, pain under ribs on left side, and inactivity. Scoring of the Total Symptom Score (TSS), in this study was based on 7 of these items, (range of 0-70,), excluding inactivity. These items assess the impact experienced by the participant in the 24 hours prior to completing the questionnaire. All items are measured using a 0 to 10 Numeric Rating Scale, with 0 corresponding to "Absent" and 10 being the worse |
| Secondary | Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Baseline to Week 24 | Rate of RBC transfusion was defined as the average number of RBC units transfused not associated with clinically overt bleeding per subject-month during the double-blind phase. |
| Secondary | RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding) | Week 24 | RBC transfusion independence is the percentage of participants who are transfusion independent at Week 24, defined as absence of RBC transfusions and no hemoglobin level below 8 g/dL in the 12 weeks prior to Week 24, excluding cases associated with clinically overt bleeding. |
| Secondary | RBC Transfusion Dependence Rate at Week 24. (Defined as Having Had at Least 4 Units of RBC Transfusions, or a Hemoglobin Level Below 8 g/dL in 8 Weeks Prior to Week 24 (Excluding Cases Associated With Clinically Overt Bleeding)). | Week 24 | RBC transfusion dependence is the percentage of participants who are transfusion dependent at Week 24, defined as having had at least 4 units of RBC transfusions, or a hemoglobin level below 8 g/dL in 8 weeks prior to Week 24 (excluding cases associated with clinically overt bleeding). Participants with the last double-blind phase participation date prior to Day 162 (ie. missing at Week 24) were considered transfusion dependent at Week 24. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Splenic Response Rate at Week 24 | Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Total Symptom Score (TSS) Response Rate at Week 24 | Week 24 | TSS rate analysis at Week 24 only included participants with TSS \> 0 at baseline or with TSS = 0 at baseline but with TSS \> 0 or missing at Week 24. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Baseline to Week 24 | units/month | MEDIAN | |
| SECONDARY | RBC Transfusion Independence Rate at Week 24, (Defined as Absence of RBC Transfusions and no Hemoglobin Level Below 8 g/dL in the 12 Weeks Prior to Week 24, Excluding Cases Associated With Clinically Overt Bleeding) | Week 24 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | RBC Transfusion Dependence Rate at Week 24. (Defined as Having Had at Least 4 Units of RBC Transfusions, or a Hemoglobin Level Below 8 g/dL in 8 Weeks Prior to Week 24 (Excluding Cases Associated With Clinically Overt Bleeding)). | Week 24 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Splenic Response Rate at Week 24 | Momelotinib (MMB) | Responder | 57 | Participants | |
| Splenic Response Rate at Week 24 | Ruxolitinib (RUX) | Responder | 64 | Participants | |
| Splenic Response Rate at Week 24 | Momelotinib (MMB) | Nonresponder | 158 | Participants | |
| Splenic Response Rate at Week 24 | Ruxolitinib (RUX) | Nonresponder | 153 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Momelotinib (MMB) | Responder | 60 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Ruxolitinib (RUX) | Responder | 89 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Momelotinib (MMB) | Nonresponder | 151 | Participants | |
| Total Symptom Score (TSS) Response Rate at Week 24 | Ruxolitinib (RUX) | Nonresponder | 122 | Participants | |
| Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Momelotinib (MMB) | 0.0 | Inter-Quartile Range 0.0 to 0.2 | units/month | |
| Rate of Red Blood Cell (RBC) Transfusions in the Double-blind Phase, (the Average Number of RBC Units Transfused Per Month Not Associated With Overt Bleeding) | Ruxolitinib (RUX) | 0.4 | Inter-Quartile Range 0.0 to 1.5 | units/month |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | Momelotinib (MMB) | 215 | |
| Double-blind Phase | STARTED | Ruxolitinib (RUX) | 217 | |
| Double-blind Phase | STARTED | MMB to MMB | 0 | |
| Double-blind Phase | STARTED | RUX to MMB | 0 | |
| Double-blind Phase | COMPLETED | Momelotinib (MMB) | 188 | |
| Double-blind Phase | COMPLETED | Ruxolitinib (RUX) | 208 | |
| Double-blind Phase | COMPLETED | MMB to MMB | 0 | |
| Double-blind Phase | COMPLETED | RUX to MMB | 0 | |
| Double-blind Phase | NOT COMPLETED | Momelotinib (MMB) | 27 | |
| Double-blind Phase | NOT COMPLETED | Ruxolitinib (RUX) | 9 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events1,116
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 | Abdominal pain | Gastrointestinal disorders | Momelotinib (MMB) | 21 | 214 | |
| other | Abdominal pain | Gastrointestinal disorders | Ruxolitinib (RUX) | 24 | 216 | |
| other | Abdominal pain | Gastrointestinal disorders | MMB to MMB | 13 | 171 | |
| other | Abdominal pain | Gastrointestinal disorders | RUX to MMB | 26 | 197 | |
| other | Alanine aminotransferase increased | Investigations | Momelotinib (MMB) | 10 | 214 | |
| other | Alanine aminotransferase increased | Investigations | Ruxolitinib (RUX) | 10 | 216 | |
| other | Alanine aminotransferase increased | Investigations | MMB to MMB | 5 | 171 | |
| other | Alanine aminotransferase increased | Investigations | RUX to MMB | 11 | 197 | |
| other | Anaemia | Blood and lymphatic system disorders | Momelotinib (MMB) | 30 | 214 | |
| other | Anaemia | Blood and lymphatic system disorders | Ruxolitinib (RUX) | 79 | 216 |
1 to 10 of 1,116Source ClinicalTrials.gov
See all 1,116 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Momelotinib (MMB) | 8 | 214 |
| Total, all-cause mortality | Ruxolitinib (RUX) | 6 | 216 |
| Total, all-cause mortality | MMB to MMB | 44 | 171 |
| Total, all-cause mortality | RUX to MMB | 54 | 197 |
| Total, other adverse events | Momelotinib (MMB) | 197 | 214 |
| Total, other adverse events | Ruxolitinib (RUX) | 206 | 216 |
| Total, other adverse events | MMB to MMB | 153 | 171 |
| Total, other adverse events | RUX to MMB | 188 | 197 |
| Total, serious adverse events | Momelotinib (MMB) | 49 | 214 |
| Total, serious adverse events | Ruxolitinib (RUX) | 39 | 216 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers7
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/NCT01969838
GET https://conductscience.org/api/trials/v1/NCT01969838/flow?page=2