Trial · NCT01715896
A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
NCT01715896, Phase 2, Completed, MedImmune LLC; results first posted 2016-10-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis. Trials, record NCT01715896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01715896
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis
- NCT number
- NCT01715896
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 215 participants, actual
- Lead sponsor
- MedImmune LLC
- Conditions
- Rheumatoid Arthritis
- Interventions
- Golimumab 50 mg, Mavrilimumab 100 mg
- First posted
- 2012-10-29
- Last updated
- 2016-10-31
- Results first posted
- 2016-10-31
- Limitations and caveats
- Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule.
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 | Day 169 | The ACR20 was defined as greater than or equal to (\>=) 20 percent (%) improvement, in: swollen joint count (SJC) and tender joint count (TJC) and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity (MDGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-reactive protein (CRP). If CRP was missing and Erythrocyte sedimentation rate (ESR) was present then ESR was to be used. |
| Primary | Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 | Day 169 | The ACR50 was defined as \>=50% improvement, in: SJC and TJC and \>=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method. |
| Primary | Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 | Day 169 | The ACR70 was defined as \>=70% improvement, in: SJC and TJC and \>=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and CRP. If CRP was missing and ESR was present then ESR was to be used. The percentage of participants were calculated by logistic regression model method. |
| Primary | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 | Day 169 | The DAS28 (CRP) was calculated from the number of SJC and TJC using the 28 joints count, The DAS28(CRP) considers 28 of the 68 TJC and 28 of the 66 SJC and participant's global health (GH) using PGA of disease activity using the visual analogue scale (VAS) of 0 (= best), 100 (= worst) plus levels of CRP (milligram/Liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, \>=3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. Participants with score less than 2.6 were analysed. The percentage of participants were calculated by logistic regression model method. |
| Primary | Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169 | Day 169 | The HAQ-DI: 20-item scale assessing participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arising, eating, hygiene, walking, reaching, grip, and errands/chores over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range from 0 to 3; where 0 = least difficulty and 3 = extreme difficulty. Participants with change from baseline more than or equal to (\>=) 0.25 were reported. The percentage of participants were calculated by logistic regression model method. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Day 169 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the 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. Treatment-emergent are events between first dose of study drug and Day 169 that were absent before treatment or that worsened relative to pre-treatment state. TEAE and TESAE were reported as per relatedness and severity. |
| Secondary | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 | Any medically significant change in laboratory evaluations were recorded as adverse events. Following parameters were analyzed for laboratory examination: hematology (leukocytosis, neutropenia, anaemia of chronic disease); serum chemistry (alanine aminotransferase, blood parathyroid hormone, gamma glutamyl transferase, hepatic enzyme, dyslipidaemia, hypercholesterolaemia, hyperglycaemia, hyperlipidaemia, hypertriglyceridaemia); urinalysis. |
| Secondary | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital signs abnormalities reported as TEAEs were reported. |
| Secondary | Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169 | Day 85 and 169 | Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), forced vital capacity (FVC), and diffusing capacity for carbon monoxide (DLCO). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. DLCO is a pulmonary function test that measures the partial pressure difference between inspired and expired carbon monoxide. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as more than (\>) 20% reduction (RD) and absolute value (AV) less than (\<) 80% predicted (PR). |
| Secondary | Dyspnea Score at Day 169 | Day 169 | Borg dyspnea scale was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The scale ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing. |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes30
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169 | Day 169 | The mITT population analysis set included all participants in the treatment group corresponding to their randomized treatment group. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | Baseline up to Day 169 | The safety population included all participants who received any amount of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 | The safety population included all participants who received any amount of investigational product. | participants | NUMBER |
| SECONDARY | Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) | Baseline up to Day 169 | The safety population included all participants who received any amount of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Pulmonary Function Test Values Below Threshold Values Based on Percent Change From Baseline at Day 85 and 169 | Day 85 and 169 | The safety population included all participants who received any amount of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively. | participants | NUMBER |
| SECONDARY | Dyspnea Score at Day 169 | Day 169 | The safety population included all participants who received any amount of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure. | units on a scale | MEAN |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 outcomesResults by group155
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 | Golimumab 50 mg Alternating With Placebo | 65.6 | percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169 | Mavrilimumab 100 mg | 62.0 | percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 | Golimumab 50 mg Alternating With Placebo | 43.4 | percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169 | Mavrilimumab 100 mg | 34.8 | percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 | Golimumab 50 mg Alternating With Placebo | 25.9 | percentage of participants | ||
| Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169 | Mavrilimumab 100 mg | 16.1 | percentage of participants | ||
| Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 | Golimumab 50 mg Alternating With Placebo | 29.0 | percentage of participants | ||
| Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 169 | Mavrilimumab 100 mg | 17.4 | percentage of participants | ||
| Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169 | Golimumab 50 mg Alternating With Placebo | 69.0 | percentage of participants | ||
| Percentage of Participants Who Achieved Health Assessment Questionnaire Disability Index (HAQ-DI) Score Improvement From Baseline and >= 0.25 at Day 169 | Mavrilimumab 100 mg | 58.7 | percentage of participants |
1 to 10 of 155Source ClinicalTrials.gov
See all 155 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Golimumab 50 Milligram (mg) Alternating With Placebo | 68 | |
| Overall Study | STARTED | Mavrilimumab 100 mg | 70 | |
| Overall Study | COMPLETED | Golimumab 50 Milligram (mg) Alternating With Placebo | 65 | |
| Overall Study | COMPLETED | Mavrilimumab 100 mg | 59 | |
| Overall Study | NOT COMPLETED | Golimumab 50 Milligram (mg) Alternating With Placebo | 3 | |
| Overall Study | NOT COMPLETED | Mavrilimumab 100 mg | 11 |
Source ClinicalTrials.gov
Adverse events76
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 | Leukocytosis | Blood and lymphatic system disorders | Golimumab 50 mg Alternating With Placebo | 0 | 68 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Mavrilimumab 100 mg | 2 | 70 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Golimumab 50 mg Alternating With Placebo | 0 | 68 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Mavrilimumab 100 mg | 2 | 70 | 2 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Golimumab 50 mg Alternating With Placebo | 1 | 68 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Mavrilimumab 100 mg | 1 | 70 | 1 |
| other | Nausea | Gastrointestinal disorders | Golimumab 50 mg Alternating With Placebo | 1 | 68 | 2 |
| other | Nausea | Gastrointestinal disorders | Mavrilimumab 100 mg | 1 | 70 | 1 |
| other | Fatigue | General disorders | Golimumab 50 mg Alternating With Placebo | 2 | 68 | 2 |
| other | Fatigue | General disorders | Mavrilimumab 100 mg | 1 | 70 | 1 |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Golimumab 50 mg Alternating With Placebo | ||
| Total, all-cause mortality | Mavrilimumab 100 mg | ||
| Total, other adverse events | Golimumab 50 mg Alternating With Placebo | 29 | 68 |
| Total, other adverse events | Mavrilimumab 100 mg | 36 | 70 |
| Total, serious adverse events | Golimumab 50 mg Alternating With Placebo | 3 | 68 |
| Total, serious adverse events | Mavrilimumab 100 mg | 2 | 70 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Golimumab 50 mg Alternating With Placebo vs Mavrilimumab 100 mg: Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab | Trial comparisons |
| Golimumab 50 mg Alternating With Placebo vs Mavrilimumab 100 mg: serious adverse events | Trial comparisons |
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/NCT01715896
GET https://conductscience.org/api/trials/v1/NCT01715896/registered?page=2