Trial · NCT01706926

A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

NCT01706926, Phase 2, Completed, MedImmune LLC; results first posted 2016-09-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis. Trials, record NCT01706926. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01706926

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis
NCT number: NCT01706926
Status: Completed
Phases: Phase 2
Enrollment: 420 participants, actual
Lead sponsor: MedImmune LLC
Conditions: Rheumatoid Arthritis
Interventions: Mavrilimumab 30 mg, Mavrilimumab 100 mg, Mavrilimumab 150 mg, Placebo
First posted: 2012-10-15
Last updated: 2016-09-27
Results first posted: 2016-09-27
Limitations and caveats: Non-compartmental analyses was not performed for pharmacokinetics parameters due to limited sampling schedule

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline and Day 85	DAS28 (CRP) calculated swollen joint count (SJC) and tender joint count (TJC) using the 28 joints, general health (GH) using participant assessment of disease activity (participant rated arthritis activity using the numerical rating scale with 0 = best, 10 = worst), and CRP (milligram per liter \[mg/L\]). Total score range: 0-9.4, higher score= more disease activity. DAS28 (CRP) less than (\<) 3.2 = low disease activity, greater than or equal to (\>=) 3.2 to 5.1 = moderate to high disease activity and \<2.6= remission. A Day 85 responder was defined as a participant who experienced more than 1.2 decrease from baseline in DAS28 (CRP) score at Day 85.
Primary	Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	Day 169	ACR20 was defined as \>=20 percent (%) improvement, in: SJC and TJC and \>=20% 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 Health Assessment Questionnaire \[HAQ\]); and CRP.
Secondary	Percentage 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 pretreatment state.
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 (haemoglobin, absolute neutrophil count, leukocyte count, platelet count), serum chemistry (alanine transaminase, aspartate transaminase, bilirubin, gamma-glutamyl transferase), other serum chemistry (low-density lipoprotein cholesterol, triglycerides), and 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	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	Day 169	Pulmonary function testing were performed by spirometry to assess forced expiratory volume in 1 second (FEV1), forced expiratory volume in 6 second (FEV6), and forced vital capacity (FVC). 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. The percentage of predicted values of these pulmonary function tests were calculated based on decreases from baseline and categorized as less than or equal to (=\<) 15 percent (%), more than (\>) 15 to =\<20%, and \>20%.
Secondary	Dyspnea Score at Day 169	Day 169	Borg dyspnea scale is 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 indicate greater difficulty in breathing.
Secondary	Oxygen Saturation Level at Day 169	Day 169	Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Secondary	Percentage of Participants Who Achieved American College of Rheumatology 50 (ACR50) Responses at Day 169	Day 169	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.
Secondary	Percentage of Participants Who Achieved American College of Rheumatology 70 (ACR70) Responses at Day 169	Day 169	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.

1 to 10 of 26Source ClinicalTrials.gov

See all 26 registered outcomes

Outcomes26

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 Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Baseline and Day 85	The modified intent-to-treat (mITT) population analysis set included all participants in the treatment group corresponding to their randomized treatment group. Here n signifies participants who were evaluable for this measure for the specified time point for each arm, respectively.	units on a scale	MEAN
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
SECONDARY	Percentage 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 dose of investigational product.	percentage of 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 dose 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 dose of investigational product.	participants	NUMBER
SECONDARY	Percentage of Pulmonary Function Test Values Below Threshold Values at Day 169	Day 169	The safety population included all participants who received any dose of investigational product. Here n signifies participants who were evaluable for this measure for the specified threshold value mentioned parameter for each arm, respectively.	percent of pulmonary test values	NUMBER
SECONDARY	Dyspnea Score at Day 169	Day 169	The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.	units on a scale	MEAN
SECONDARY	Oxygen Saturation Level at Day 169	Day 169	The safety population included all participants who received any dose of investigational product. Here N (number of participants analyzed) signifies participants who were evaluable for this measure.	percent saturation	MEAN
SECONDARY	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
SECONDARY	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

1 to 10 of 26Source ClinicalTrials.gov

See all 26 outcomes

Results by group265

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 Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Placebo	Baseline (n=81, 81, 85, 79)	5.78	Standard Error 0.090	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Mavrilimumab 30 mg	Baseline (n=81, 81, 85, 79)	5.73	Standard Error 0.104	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Mavrilimumab 100 mg	Baseline (n=81, 81, 85, 79)	5.91	Standard Error 0.096	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Mavrilimumab 150 mg	Baseline (n=81, 81, 85, 79)	5.67	Standard Error 0.086	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Placebo	Change at Day 85 (n=77, 76, 79, 78)	-0.68	Standard Error 0.136	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Mavrilimumab 30 mg	Change at Day 85 (n=77, 76, 79, 78)	-1.37	Standard Error 0.136	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Mavrilimumab 100 mg	Change at Day 85 (n=77, 76, 79, 78)	-1.64	Standard Error 0.132	units on a scale
Change From Baseline in Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Score at Day 85	Mavrilimumab 150 mg	Change at Day 85 (n=77, 76, 79, 78)	-1.90	Standard Error 0.136	units on a scale
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	Placebo		24.7		percentage of participants
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Responses at Day 169	Mavrilimumab 30 mg		50.6		percentage of participants

1 to 10 of 265Source ClinicalTrials.gov

See all 265 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	81
Overall Study	STARTED	Mavrilimumab 30 mg	81
Overall Study	STARTED	Mavrilimumab 100 mg	85
Overall Study	STARTED	Mavrilimumab 150 mg	79
Overall Study	COMPLETED	Placebo	75
Overall Study	COMPLETED	Mavrilimumab 30 mg	77
Overall Study	COMPLETED	Mavrilimumab 100 mg	79
Overall Study	COMPLETED	Mavrilimumab 150 mg	74
Overall Study	NOT COMPLETED	Placebo	6
Overall Study	NOT COMPLETED	Mavrilimumab 30 mg	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events592

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	Anaemia	Blood and lymphatic system disorders	Placebo	1	81	1
other	Anaemia	Blood and lymphatic system disorders	Mavrilimumab 30 mg	1	81	1
other	Anaemia	Blood and lymphatic system disorders	Mavrilimumab 100 mg	0	85	0
other	Anaemia	Blood and lymphatic system disorders	Mavrilimumab 150 mg	0	79	0
other	Eosinophilia	Blood and lymphatic system disorders	Placebo	0	81	0
other	Eosinophilia	Blood and lymphatic system disorders	Mavrilimumab 30 mg	0	81	0
other	Eosinophilia	Blood and lymphatic system disorders	Mavrilimumab 100 mg	1	85	1
other	Eosinophilia	Blood and lymphatic system disorders	Mavrilimumab 150 mg	0	79	0
other	Leukocytosis	Blood and lymphatic system disorders	Placebo	2	81	2
other	Leukocytosis	Blood and lymphatic system disorders	Mavrilimumab 30 mg	0	81	0

1 to 10 of 592Source ClinicalTrials.gov

See all 592 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Mavrilimumab 30 mg
Total, all-cause mortality	Mavrilimumab 100 mg
Total, all-cause mortality	Mavrilimumab 150 mg
Total, other adverse events	Placebo	38	81
Total, other adverse events	Mavrilimumab 30 mg	41	81
Total, other adverse events	Mavrilimumab 100 mg	36	85
Total, other adverse events	Mavrilimumab 150 mg	43	79
Total, serious adverse events	Placebo	1	81
Total, serious adverse events	Mavrilimumab 30 mg	4	81

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28213566	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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