Trial · NCT01712399
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
NCT01712399, Phase 2, Terminated, MedImmune LLC; results first posted 2017-06-01
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis. Trials, record NCT01712399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
- NCT number
- NCT01712399
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 409 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Rheumatoid Arthritis
- Interventions
- Mavrilimumab 100 mg
- First posted
- 2012-10-23
- Last updated
- 2017-06-01
- Results first posted
- 2017-06-01
- Limitations and caveats
- The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. |
| Primary | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) | Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. |
| Primary | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. |
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) | The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. |
| Primary | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | From Week 24 to Week 130 at specified time points | Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=\<)15% reduction from baseline, greater than (\>)15% to =\<20% reduction from baseline, \>20% reduction from baseline and \>20% reduction to \<80%. The threshold values refer to baseline values for each participant. |
| Primary | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | From Week 24 to Week 130 at specified time points | Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =\<15% reduction from baseline, \>15% to =\<20% reduction from baseline, \>20% reduction from baseline and \>20% reduction to \<80%. The threshold values refer to baseline values for each participant. |
| Primary | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | From Week 24 to Week 156 at specified time points | Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =\<15% reduction from baseline, \>15% to =\<20% reduction from baseline, \>20% reduction from baseline and \>20% reduction to \<80%. The threshold values refer to baseline values for each participant. |
| Primary | Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE | From Week 0 to Week 132 at specified time points | Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing. |
| Primary | Oxygen Saturation Levels by Pulse Oximetry | From Week 0 to Week 132 at specified time points | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. |
| Primary | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | From Week 12 to Week 156 at specified time points | DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years) | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Participants | NUMBER |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Participants | NUMBER |
| PRIMARY | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | From Week 24 to Week 130 at specified time points | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| PRIMARY | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | From Week 24 to Week 130 at specified time points | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| PRIMARY | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | From Week 24 to Week 156 at specified time points | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Participants | NUMBER |
| PRIMARY | Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE | From Week 0 to Week 132 at specified time points | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Participants | NUMBER |
| PRIMARY | Oxygen Saturation Levels by Pulse Oximetry | From Week 0 to Week 132 at specified time points | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Percent saturation | MEAN |
| PRIMARY | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | From Week 12 to Week 156 at specified time points | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | (mL/min/mmHg) | MEAN |
Source ClinicalTrials.gov
Results by group124
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Mavrilimumab 100 mg | TEAEs | 288 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Mavrilimumab 100 mg | TESAEs | 46 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Anaemia | 8 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Eosinophilia | 1 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Iron deficiency anaemia | 2 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Leukocytosis | 1 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Leukopenia | 1 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Lymphadenopathy | 1 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Neutropenia | 2 | Participants | |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Mavrilimumab 100 mg | Spontaneous haematoma | 1 | Participants |
1 to 10 of 124Source ClinicalTrials.gov
See all 124 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mavrilimumab 100 mg | 397 | |
| Overall Study | COMPLETED | Mavrilimumab 100 mg | 0 | |
| Overall Study | NOT COMPLETED | Mavrilimumab 100 mg | 397 |
Source ClinicalTrials.gov
Adverse events64
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 | Dental caries | Gastrointestinal disorders | Mavrilimumab 100 mg | 8 | 397 | 9 |
| other | Diarrhoea | Gastrointestinal disorders | Mavrilimumab 100 mg | 15 | 397 | 15 |
| other | Bronchitis | Infections and infestations | Mavrilimumab 100 mg | 44 | 397 | 59 |
| other | Gastroenteritis | Infections and infestations | Mavrilimumab 100 mg | 11 | 397 | 14 |
| other | Influenza | Infections and infestations | Mavrilimumab 100 mg | 23 | 397 | 26 |
| other | Nasopharyngitis | Infections and infestations | Mavrilimumab 100 mg | 59 | 397 | 90 |
| other | Oral herpes | Infections and infestations | Mavrilimumab 100 mg | 11 | 397 | 13 |
| other | Pharyngitis | Infections and infestations | Mavrilimumab 100 mg | 18 | 397 | 20 |
| other | Respiratory tract infection | Infections and infestations | Mavrilimumab 100 mg | 13 | 397 | 21 |
| other | Rhinitis | Infections and infestations | Mavrilimumab 100 mg | 9 | 397 | 10 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mavrilimumab 100 mg | ||
| Total, other adverse events | Mavrilimumab 100 mg | 214 | 397 |
| Total, serious adverse events | Mavrilimumab 100 mg | 46 | 397 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29361199 | DERIVED |
Source PubMed
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/NCT01712399
GET https://conductscience.org/api/trials/v1/NCT01712399/results?page=2