Phase 3
Completed N=2,243
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Source: ClinicalTrials.gov NCT00790933 ↗Enrolled (actual)
2,243
Serious AEs
36.8%
Results posted
Mar 2019
Primary outcomePrimary: Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 93; 96; 31; 41 percentage of participants
◆ Published Evidence
Highly cited
190citations · ~24 / year
Effect of vedolizumab (anti-α4β7-integrin) therapy on histological healing and mucosal gene expression in patients with UC.
Summary
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
Linked Publications (5)
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Effect of vedolizumab (anti-α4β7-integrin) therapy on histological healing and mucosal gene expression in patients with UC.
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Long-term safety of vedolizumab for inflammatory bowel disease.
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Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis.
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Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis.
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Vedolizumab Immunogenicity With Long-Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
93; 96; 31; 41 | — |
| PRIMARY Number of Participants With Markedly Abnormal Safety Laboratory Findings |
16; 11; 28; 56; 1; 3 | — |
| PRIMARY Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements |
0; 0 | — |
| PRIMARY Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings |
7; 7 | — |
| PRIMARY Time to Major Inflammatory Bowel Disease (IBD) - Related Events |
NA; NA | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 |
125.34; 129.12; 124.37; 122.33; 127.56; 127.11 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 |
123.53; 131.17; 125.03; 120.29; 129.46; 128.69 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 |
123.66; 131.31; 123.87; 120.00; 128.47; 129.06 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 |
124.70; 130.90; 124.52; 120.89; 129.53; 128.25 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 |
127.33; 130.83; 123.65; 119.77; 132.36; 130.01 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 |
127.33; 131.95; 123.02; 119.07; 132.23; 130.25 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 |
130.25; 132.93; 123.47; 120.49; 131.60; 132.31 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 |
127.33; 135.33; 122.00; 119.35; 130.39; 132.16 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 |
116.05; 133.61; 120.28; 116.63; 131.81; 129.37 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 |
100.71; 137.50; 120.38; 119.67; 134.88; 121.38 | — |
| PRIMARY Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 |
89.00; 120.00; 118.00; 70.00; 137.00; 126.00 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 |
39.57; 41.15; 40.05; 37.05; 37.87; 39.09 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 |
39.98; 40.70; 38.28; 35.49; 38.53; 37.70 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 |
39.94; 41.72; 40.12; 36.75; 37.82; 39.23 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 |
39.33; 41.18; 38.29; 35.43; 39.45; 38.98 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 |
39.79; 41.33; 40.07; 37.03; 37.92; 39.59 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 |
39.41; 41.30; 38.26; 35.50; 38.86; 38.52 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 |
41.26; 41.03; 40.29; 36.97; 38.11; 39.59 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 |
39.56; 41.10; 38.21; 35.61; 38.76; 37.41 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 |
41.75; 41.08; 39.88; 37.00; 38.58; 39.31 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 |
40.34; 40.81; 37.85; 35.29; 38.59; 38.33 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 |
41.75; 41.33; 39.86; 36.68; 39.22; 39.21 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 |
40.34; 41.20; 37.48; 35.05; 38.56; 39.21 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 |
42.23; 41.52; 40.23; 37.29; 38.82; 39.16 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 |
40.79; 41.49; 37.00; 35.47; 38.77; 39.83 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 |
40.72; 40.83; 40.52; 35.64; 36.65; 39.33 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 |
39.46; 42.74; 40.40; 36.17; 39.07; 37.63 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 |
39.99; 40.71; 39.33; 37.54; 38.32; 40.28 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 |
38.00; 41.76; 38.01; 34.26; 38.06; 38.04 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 |
36.89; 38.84; 39.22; 36.56; 34.80; 39.97 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 |
34.53; 43.55; 35.77; 33.38; 39.40; 35.79 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 |
35.68; 38.32; 44.36; 31.07; 37.14; 33.67 | — |
| PRIMARY Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 |
42.19; 35.34; 32.72; 22.18; 39.80; 42.98 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 |
7.42; 7.21; 7.54; 8.00; 7.77; 7.73 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 |
58.4; 62.1; 53.5; 51.5; 52.2; 52.3 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 |
7.50; 7.17; 7.54; 8.08; 7.75; 7.65 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 |
57.5; 61.9; 52.3; 50.8; 52.6; 52.7 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 |
7.48; 7.18; 7.56; 8.11; 7.72; 7.64 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 |
58.8; 62.3; 52.0; 50.7; 52.0; 52.4 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 |
7.48; 7.22; 7.55; 8.04; 7.69; 7.67 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 |
59.2; 61.3; 52.9; 50.7; 53.8; 51.9 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 |
7.33; 7.24; 7.61; 8.14; 7.62; 7.69 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 |
61.2; 61.6; 52.0; 50.0; 54.8; 52.4 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 |
7.33; 7.20; 7.64; 8.17; 7.60; 7.65 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 |
61.2; 61.5; 51.4; 49.4; 54.3; 52.1 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 |
7.28; 7.17; 7.67; 8.03; 7.65; 7.70 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 |
61.6; 62.1; 51.3; 49.7; 54.2; 52.4 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 |
7.33; 7.14; 7.54; 8.11; 7.68; 7.66 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 |
61.2; 61.3; 52.5; 49.0; 54.2; 52.8 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 |
7.48; 7.21; 7.69; 8.09; 7.66; 7.84 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 |
57.2; 61.6; 52.1; 47.2; 52.3; 53.2 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 |
8.14; 7.50; 8.08; 8.33; 7.88; 7.94 | — |
| PRIMARY Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 |
58.1; 64.9; 55.7; 50.4; 53.1; 42.9 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 |
8.00; 8.00; 8.33; 12.00; 8.00; 9.00 | — |
| PRIMARY Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 |
52.0; 50.0; 48.0; 15.0; 50.0; 31.0 | — |
Eligibility Criteria
Inclusion Criteria
- Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
- May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol
Exclusion Criteria
- Development of any new, unstable, or uncontrolled disease
Data sourced from ClinicalTrials.gov (NCT00790933) and the linked publication. 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.