Crohn Disease
Conditions
Brief summary
Primary Objective: The primary objective of this trial is to compare the clinical efficacy of BI 695501 with EU-approved Humira® in patients with active Crohn's disease (CD). Secondary Objectives: The secondary objectives of this trial are to compare the efficacy and safety of BI 695501 with EU-approved Humira® across the induction and maintenance phases.
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged \>=18 and =\<80 years at Screening who have a diagnosis of moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must have all of the following: * Crohn's Disease Activity Index (CDAI) score of \>=220 and =\<450 * A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening * Presence of mucosal ulcers in at least one segment of the ileum or colon and a SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as assessed by ileocolonoscopy and confirmed by central independent reviewer(s) before randomization * Anti-tumor necrosis factor (TNF) patients or patients previously treated with infliximab who had initially responded and who meet one of the following criteria: * Responded and developed secondary resistance due confirmed anti-infliximab anti-drug antibody formation, which caused infliximab depletion * Responded and became intolerant * Further inclusion criteria apply
Exclusion criteria
* Patients with ulcerative colitis or indeterminate colitis * Patients with symptomatic known obstructive strictures * Surgical bowel resection performed within 6 months prior to Screening or planned resection at any time while enrolled in the trial * Patients with an ostomy or ileoanal pouch * Patients with short bowel syndrome * Patients who have previously used infliximab and have never clinically responded * Patients who have previously received treatment with adalimumab, or who have participated in an adalimumab or adalimumab biosimilar clinical trial * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 | Week 4 | The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients in Clinical Remission (CDAI <150) at Week 24 | at Week 24 | The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. Patients with CDAI \<150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF. |
| Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. | Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions. |
| Percentage of Patients With Infections | From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. | The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. |
| Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24 | Week 24 | The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF. |
| Percentage of Patients Who Experienced Hypersensitivity Reactions | From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. | The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. |
| Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) | From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. | The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. |
| Percentage of Patients With Injection Site Reactions | From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. | The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. |
| Percentage of Patients With Serious Infections | From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks. | The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. |
Countries
Belarus, Bosnia and Herzegovina, Croatia, Czechia, Germany, Greece, Israel, Poland, Russia, Serbia, Turkey (Türkiye), Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This was an exploratory, randomized, 56-week, double-blind, parallel arm, multiple dose, active comparator trial of BI 695501 and EU-approved Humira, with a 48-week treatment period and a 10-week follow-up period (starting after last dose of trial medication at Week 46) in patients with moderately to severely active Crohn's Disease (CD)
Pre-assignment details
The trial consisted of a screening period of up to a maximum of 28 days, a 48-week treatment period consisting of an induction period from baseline to Week 4 and a maintenance period from Week 5 to Week 48, and a 10-week safety follow-up period (starting after last dose of trial medication at Week 46).
Participants by arm
| Arm | Count |
|---|---|
| BI 695501 Patients randomized to BI 695501 received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders (Crohn's Disease Activity Index (CDAI) decrease of ≥70 compared to baseline), patients continued to receive BI 695501 every 2 weeks until the end of the treatment (EoT) period (Week 46).
Patients were administered with a loading dose of 160 milligram (mg) BI 695501 on Day 1, followed by 80 mg BI 695501 2 weeks later (Day 15), and thereafter 40 mg BI 695501 every 2 weeks until Week 46. Trial medication was administered by subcutaneous (SC) injection. | 72 |
| Humira EU Patients randomized to EU-approved Humira received treatment every 2 weeks until Week 4 when they were assessed for clinical response. If classified as responders, patients continued to receive EU-approved Humira until Week 22 and then switched to receive BI 695501 every 2 weeks from Week 24 until the EoT period (Week 46).
Patients were administered with a loading dose of 160 mg EU-approved Humira on Day 1, followed by 80 mg EU-approved Humira 2 weeks later (Day 15), and 40 mg EU-approved Humira every 2 weeks until Week 22. Patients were then switched to receive 40 mg BI 695501 every 2 weeks from Week 24 until Week 46. Trial medication was administered by SC injection. | 75 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 |
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Primary lack of efficacy | 4 | 4 |
| Overall Study | Protocol Violation | 3 | 1 |
| Overall Study | Secondary lack of efficacy | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | BI 695501 | Humira EU | Total |
|---|---|---|---|
| Age, Continuous | 37.4 years STANDARD_DEVIATION 13.44 | 33.2 years STANDARD_DEVIATION 11.52 | 35.3 years STANDARD_DEVIATION 12.63 |
| Crohn's Disease Activity Index score at baseline | 307.3 Scores on a scale STANDARD_DEVIATION 76.69 | 303.6 Scores on a scale STANDARD_DEVIATION 64.39 | 305.4 Scores on a scale STANDARD_DEVIATION 70.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 67 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 8 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 69 Participants | 74 Participants | 143 Participants |
| Sex: Female, Male Female | 33 Participants | 31 Participants | 64 Participants |
| Sex: Female, Male Male | 39 Participants | 44 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 75 | 0 / 72 | 0 / 75 |
| other Total, other adverse events | 23 / 72 | 16 / 75 | 13 / 72 | 12 / 75 |
| serious Total, serious adverse events | 6 / 72 | 8 / 75 | 2 / 72 | 9 / 75 |
Outcome results
Primary
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4
The Crohn's Disease Activity Index (CDAI) is a validated instrument to measure disease severity in Crohn's Disease (CD). The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 4 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to non-responder imputation (NRI) and last observation carried forward (LOCF).
Time frame: Week 4
Population: The full analysis set (FAS) contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BI 695501 | Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 | 88.0 Percentage of participants |
| Humira EU | Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 4 | 93.1 Percentage of participants |
Comparison: Was analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)90% CI: [0.87, 1.028]
Comparison: Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 4 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)95% CI: [0.856, 1.044]
Secondary
Percentage of Patients in Clinical Remission (CDAI <150) at Week 24
The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. Patients with CDAI \<150 at Week 24 were considered as clinical remission cases. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Time frame: at Week 24
Population: The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BI 695501 | Percentage of Patients in Clinical Remission (CDAI <150) at Week 24 | 68.6 Percentage of participants |
| Humira EU | Percentage of Patients in Clinical Remission (CDAI <150) at Week 24 | 76.2 Percentage of participants |
Comparison: Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)90% CI: [0.751, 1.078]
Comparison: Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)95% CI: [0.725, 1.116]
Secondary
Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI)
The percentage of patients with TEAEs for DILIs is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI 695501 | Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) | Period 2 | 0.0 Percentage of participants |
| BI 695501 | Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) | Period 1 | 0.0 Percentage of participants |
| Humira EU | Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) | Period 1 | 0.0 Percentage of participants |
| Humira EU | Percentage of Patients Who Experienced Drug Induced Liver Injury (DILI) | Period 2 | 0.0 Percentage of participants |
Secondary
Percentage of Patients Who Experienced Hypersensitivity Reactions
The percentage of patients with TEAEs for hypersensitivity reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI 695501 | Percentage of Patients Who Experienced Hypersensitivity Reactions | Period 1 | 5.6 Percentage of participants |
| BI 695501 | Percentage of Patients Who Experienced Hypersensitivity Reactions | Period 2 | 2.8 Percentage of participants |
| Humira EU | Percentage of Patients Who Experienced Hypersensitivity Reactions | Period 1 | 2.7 Percentage of participants |
| Humira EU | Percentage of Patients Who Experienced Hypersensitivity Reactions | Period 2 | 6.7 Percentage of participants |
Secondary
Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24
The CDAI is a validated instrument to measure disease severity in CD. The CDAI score is a sum of the 8 factors (number of liquid stools, abdominal pain, general well-being, extra-intestinal complications, antidiarrheal drugs, abdominal mass, hematocrit and body weight) after adjustment with a weighting factor. Higher CDAI scores indicating more active disease. The CDAI decrease at Week 24 was assessed as the decrease relative to baseline measurement, patients with a decrease ≥70 were responders. Percentage=least squares means per treatment group back transformed using inverse logit function. Missing data were imputed according to NRI and LOCF.
Time frame: Week 24
Population: The FAS contained all randomized patients who received at least 1 dose of trial medication, and had all efficacy measures relevant for the CDAI, measured at baseline and at least once postbaseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BI 695501 | Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24 | 87.4 Percentage of participants |
| Humira EU | Percentage of Patients With a Clinical Response (CDAI Decrease of ≥70 Compared With Baseline) at Week 24 | 87.4 Percentage of participants |
Comparison: Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)90% CI: [0.871, 1.148]
Comparison: Was to be analyzed using a log-linked binomial model, described as: response to treatment at Week 24 = treatment+prior infliximab exposure+screening Simple Endoscopic Score for Crohn's Disease (SES-CD)95% CI: [0.848, 1.178]
Secondary
Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs)
Analysis of AEs focused on treatment-emergent AEs (TEAEs). For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46. TEAEs and SAEs (including investigator-assessed trial medication-related TEAEs) and AESIs are reported. The following were considered an AESI: hepatic injury, anaphylactic reactions, serious infection and hypersensitivity reactions.
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Population: The Safety Analysis Set (SAF) contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI 695501 | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | TEAE -Period 1 | 62.5 Percentage of participants |
| BI 695501 | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | serious TEAE - Period 1 | 8.3 Percentage of participants |
| BI 695501 | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | AESI TEAE - Period 1 | 2.8 Percentage of participants |
| BI 695501 | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | TEAE - Period 2 | 43.1 Percentage of participants |
| BI 695501 | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | serious TEAE - Period 2 | 2.8 Percentage of participants |
| BI 695501 | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | AESI TEAE - Period 2 | 2.8 Percentage of participants |
| Humira EU | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | serious TEAE - Period 2 | 12.0 Percentage of participants |
| Humira EU | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | TEAE -Period 1 | 56.0 Percentage of participants |
| Humira EU | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | TEAE - Period 2 | 45.3 Percentage of participants |
| Humira EU | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | serious TEAE - Period 1 | 10.7 Percentage of participants |
| Humira EU | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | AESI TEAE - Period 2 | 2.7 Percentage of participants |
| Humira EU | Percentage of Patients With Adverse Events (AEs), Serious AEs (SAEs), and AEs of Special Interest (AESIs) | AESI TEAE - Period 1 | 2.7 Percentage of participants |
Secondary
Percentage of Patients With Infections
The percentage of patients with TEAEs for infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI 695501 | Percentage of Patients With Infections | Period 1 | 23.6 Percentage of participants |
| BI 695501 | Percentage of Patients With Infections | Period 2 | 19.4 Percentage of participants |
| Humira EU | Percentage of Patients With Infections | Period 1 | 22.7 Percentage of participants |
| Humira EU | Percentage of Patients With Infections | Period 2 | 22.7 Percentage of participants |
Secondary
Percentage of Patients With Injection Site Reactions
The percentage of patients with TEAEs for injection site reactions is reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI 695501 | Percentage of Patients With Injection Site Reactions | Period 1 | 0.0 Percentage of participants |
| BI 695501 | Percentage of Patients With Injection Site Reactions | Period 2 | 1.4 Percentage of participants |
| Humira EU | Percentage of Patients With Injection Site Reactions | Period 1 | 6.7 Percentage of participants |
| Humira EU | Percentage of Patients With Injection Site Reactions | Period 2 | 1.3 Percentage of participants |
Secondary
Percentage of Patients With Serious Infections
The percentage of patients with TEAEs for serious infections are reported. For the period 1 'Baseline - Week 24', TEAEs were defined as AEs that started or worsened on or after first dose of trial medication and prior to date of the Week 24 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients who discontinued treatment before Week 24. For the period 2 'Week 24 - Week 46', TEAEs were defined as AEs that started or worsened on Week 24 visit and prior to or on Week 56 visit or within 10 weeks (70 days, inclusive) after last dose of trial medication for patients discontinuing treatment prior to Week 46.
Time frame: From first administration of trial medication until 10 weeks after last administration, up to a maximum of 56 weeks.
Population: The SAF contained all randomized patients who received at least 1 dose (full or partial) of trial medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BI 695501 | Percentage of Patients With Serious Infections | Period 1 | 2.8 Percentage of participants |
| BI 695501 | Percentage of Patients With Serious Infections | Period 2 | 1.4 Percentage of participants |
| Humira EU | Percentage of Patients With Serious Infections | Period 1 | 2.7 Percentage of participants |
| Humira EU | Percentage of Patients With Serious Infections | Period 2 | 4.0 Percentage of participants |