Phase 2
Completed N=290
A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01050998 ↗Enrolled (actual)
290
Serious AEs
2.1%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 — 32.6; 37.5; 63.3; 47.9 percentage of participants — p=0.578
Summary
The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 |
32.6; 37.5; 63.3; 47.9; 68.1 | 0.578 |
| PRIMARY Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using C-Reactive Protein (DAS28 [CRP]) Response at Day 85 by Region |
34.7; 41.0; 61.0; 51.3; 66.7; 23.5 | 0.543 |
| PRIMARY Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 |
37.0; 50.0; 61.2; 58.3; 66.0 | 0.152 |
| PRIMARY Percentage of Participants Who Achieved Disease Activity Score of 28 Joints Using Erythrocyte Sedimentation Rate (DAS28 [ESR]) at Day 85 by Region |
41.3; 51.3; 58.5; 61.5; 64.1; 17.6 | 0.328 |
| PRIMARY Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 |
51.1; 47.9; 28.6; 35.4; 23.4; 34.8 | — |
| PRIMARY Percentage of Participants Who Achieved DAS28 (CRP) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region |
49.3; 46.2; 29.3; 33.3; 23.1; 36.0 | — |
| PRIMARY Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 |
55.4; 39.6; 36.7; 33.3; 25.5; 35.9 | — |
| PRIMARY Percentage of Participants Who Achieved DAS28 (ESR) Response by European League Against Rheumatism (EULAR) Category at Day 85 by Region |
53.3; 38.5; 39.0; 33.3; 28.2; 38.7 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
46; 33; 31; 26; 28; 1 | — |
| PRIMARY Number of Participants With Abnormal Vital Signs Reported as Treatment-Emergent Adverse Events (TEAEs) |
1; 0; 0; 2; 0; 2 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) Results |
0; 1; 0; 0; 2 | — |
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 |
2.730; 2.877; 2.949; 2.701; 2.793; 3.439 | — |
| PRIMARY Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 by Region |
2.811; 2.902; 3.042; 2.698; 2.848; 3.537 | — |
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at Day 85 |
2.790; 2.788; 2.990; 2.760; 2.831; -0.039 | — |
| PRIMARY Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 |
91.7; 95.0; 95.0; 95.0; 89.3 | — |
| PRIMARY Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 by Region |
90.4; 96.0; 94.0; 94.8; 88.6; 97.6 | — |
| PRIMARY Change From Baseline in Diffusing Capacity for Carbon Monoxide (DLCO) at Day 85 |
91.5; 96.3; 93.7; 97.5; 92.5; 0.1 | — |
| PRIMARY Dyspnea Score at Day 85 |
0.25; 0.13; 0.35; 0.15; 0.35 | — |
| PRIMARY Change From Baseline in Dyspnea Score at Day 85 |
0.29; 0.26; 0.26; 0.19; 0.32; -0.06 | — |
| PRIMARY Categorized Dyspnea Score at Day 85 |
89; 45; 45; 49; 46; 0 | — |
| PRIMARY Oxygen Saturation Level at Day 85 |
97.5; 97.6; 97.7; 97.2; 97.3 | — |
| PRIMARY Oxygen Saturation Level at Day 85 by Region |
97.5; 97.6; 97.6; 97.2; 97.3; 97.6 | — |
| PRIMARY Change From Baseline in Oxygen Saturation Level at Day 85 |
97.5; 97.8; 97.6; 97.6; 97.2; 0.0 | — |
| PRIMARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as Treatment-Emergent Adverse Events (TEAEs) |
10; 3; 3; 3; 4; 3 | — |
| SECONDARY Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 |
5.43; 5.24; 5.42; 5.14; 5.34; -0.97 | 0.137 |
| SECONDARY Change From Baseline in DAS28 (CRP) and DAS28 (ESR) at Day 85 by Region |
5.58; 5.30; 5.48; 5.33; 5.41; -1.00 | 0.086 |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 |
7.6; 14.6; 22.4; 18.8; 23.4; 3.3 | 0.238 |
| SECONDARY Percentage of Participants Who Achieved DAS28 (CRP) and DAS28 (ESR) Remission at Day 85 by Region |
6.7; 15.4; 17.1; 17.9; 23.1; 1.3 | 0.182 |
| SECONDARY Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission |
88.0; 84.0; 43.0; 71.0; 42.0; NA | 0.604 |
| SECONDARY Time to Onset for DAS28 (CRP) and DAS (ESR) Response and Remission by Region |
85.0; 43.0; 43.0; 50.0; 42.0; NA | 0.237 |
| SECONDARY Duration of DAS28 (CRP) and DAS28 (ESR) Response and Remission |
43.40; 42.19; 81.89; 54.80; 83.07; 46.11 | 0.486 |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 |
37.0; 41.7; 57.1; 37.5; 70.2; 12.0 | 0.589 |
| SECONDARY Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20), ACR50 and ACR70 Responses at Day 85 by Region |
40.0; 41.0; 56.1; 41.0; 69.2; 23.5 | 1.000 |
| SECONDARY Number of Participants Who Achieved ACR Categorical Responses |
58; 28; 21; 30; 14; 23 | — |
| SECONDARY Continuous ACR (ACRn) Score |
5.09; 19.13; 26.31; 12.17; 37.11 | 0.051 |
| SECONDARY Continuous ACR (ACRn) Score by Region |
4.71; 19.18; 24.12; 12.53; 36.06; 5.99 | 0.071 |
| SECONDARY Swollen and Tender Joint Count |
9.2; 8.0; 5.4; 5.8; 4.4; 14.8 | — |
| SECONDARY Swollen and Tender Joint Count by Region |
9.6; 8.0; 5.6; 6.4; 4.2; 7.6 | — |
| SECONDARY Physician Global Assessment of Disease Activity Score |
3.82; 3.30; 3.13; 3.45; 2.95 | — |
| SECONDARY Physician Global Assessment of Disease Activity Score by Region |
3.93; 3.29; 3.20; 3.54; 3.12; 3.31 | — |
| SECONDARY Patient Global Assessment of Disease Activity Score |
45.1; 40.0; 37.2; 41.1; 35.5 | — |
| SECONDARY Patient Global Assessment of Disease Activity Score by Region |
45.9; 39.5; 39.0; 42.5; 37.3; 41.5 | — |
| SECONDARY Patient Pain Assessment Score |
44.5; 38.7; 38.1; 40.1; 34.4 | — |
| SECONDARY Patient Pain Assessment Score by Region |
44.9; 38.1; 39.1; 41.4; 36.0; 42.6 | — |
| SECONDARY Health Assessments Questionnaire-Disability Index (HAQ-DI) Score |
1.19; 1.02; 1.02; 1.10; 0.95 | — |
| SECONDARY Health Assessments Questionnaire-Disability Index (HAQ-DI) Score by Region |
1.22; 1.10; 1.05; 1.16; 1.03; 1.09 | — |
| SECONDARY Health Assessments Questionnaire (HAQ) Pain Score |
46.3; 40.9; 39.0; 42.6; 35.0 | — |
| SECONDARY Health Assessments Questionnaire (HAQ) Pain Score by Region |
47.0; 40.3; 40.6; 43.8; 36.5; 43.1 | — |
| SECONDARY Serum Concentration of C-Reactive Protein (CRP) |
11.49; 9.62; 9.35; 5.71; 6.12 | — |
| SECONDARY Serum Concentration of C-Reactive Protein (CRP) by Region |
11.89; 8.86; 10.24; 6.50; 5.84; 9.75 | — |
| SECONDARY Serum Concentration of Erythrocyte Sedimentation Rate (ESR) |
34.4; 31.3; 34.1; 29.7; 23.6 | — |
| SECONDARY Serum Concentration of Erythrocyte Sedimentation Rate (ESR) by Region |
33.9; 30.3; 33.2; 32.7; 23.1; 36.6 | — |
| SECONDARY Serum Concentration of Rheumatoid Factor (RF) |
109.82; 79.62; 177.84; 85.15; 83.26 | — |
| SECONDARY Serum Concentration of Anti-Citrullinated-Peptide-Antibody (ACPA) |
295.90; 232.22; 211.77; 330.82; 221.18 | — |
| SECONDARY Number of Participants Who Had Additional Medications |
88; 47; 49; 47; 45; 45 | — |
| SECONDARY Number of Participants With Change in Methotrexate (MTX) and Corticosteroid (CST) Dose |
39; 18; 24; 29; 21; 44 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After First Dose by Region |
128; 917; 1240; 6500; 61.3; 633 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After First Dose by Region |
4; 3; 4; 4; 6; 7 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After First Dose by Region |
860; 6330; 10200; 62500; 504; 5820 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) for Mavrilimumab After Last Dose by Region |
137; 1030; 2950; 7880; 136; 1200 | — |
| SECONDARY Time to Reach Maximum Observed Serum Concentration (Tmax) for Mavrilimumab After Last Dose by Region |
3; 3; 3; 3; 3; 3 | — |
| SECONDARY Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) for Mavrilimumab After Last Dose by Region |
1060; 9260; 27900; 80500; 915; 12100 | — |
| SECONDARY Terminal Phase Elimination Half-Life (t1/2) for Mavrilimumab After Last Dose by Region |
5.56; 4.37; 6.33; 6.84; 6.96; 7.23 | — |
| SECONDARY Accumulation Ratio for Mavrilimumab After Last Dose by Region |
1.22; 1.36; 2.57; 1.29; 1.82; 1.66 | — |
| SECONDARY Number of Participants Exhibiting Anti-Drug Antibodies (ADAs) to Mavrilimumab at Any Visit |
3; 10; 6; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 through 80 years (20 to 75 years in Japan)
- Written consent
- Diagnosis of adult onset Rheumatoid Arthritis (RA) of at least 3 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988)
- Treatment with methotrexate at a stable and tolerated doses
- Positive anti-cyclic citrullinated peptide (CCP) immuno-globulin G antibodies (more than [>] 5 international unit per milliliter [IU/mL]) and/or rheumatoid factor (RF >14 IU/mL) at screening
- Received more than or equal to (>=) 5 milligram (mg) per week folic acid as a single or divided dose during the study.
Exclusion Criteria
- A rheumatic autoimmune disease other than RA
- A history of, or current, inflammatory joint disease other than RA or other systemic autoimmune disorder
- Subjects at a high risk of infection
- Subjects (male and female) of reproductive potential who are not willing to use contraception from screening through the end date of the trial
- History of methotrexate or any drug-induced lung fibrosis or pneumonitis.
Data sourced from ClinicalTrials.gov (NCT01050998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.