Ulcerative Colitis
Conditions
Keywords
Anti-TNF Refractory, Active Ulcerative Colitis, Immunosuppressant Refractory
Brief summary
Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.
Interventions
DRUG75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.
DRUG225mg SHP647 (PF-00547659)
225 mg sterile liquid injected subcutaneously every 4 weeks.
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 66 Years
Healthy volunteers
No
Inclusion criteria
* Subjects between 18 and 66 years of age. * Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.
Exclusion criteria
* Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study. * Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | From start of study drug administration up to 168 weeks | An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Mucosal Healing at Week 16 | Week 16 | Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment \[PGA\]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported. |
| Serum Trough Concentrations of SHP647 Versus Time | Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156 | Serum trough concentrations of SHP647 versus time was reported. |
| Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Baseline, Week 8, 16, 24, 40, 48, 64 and 156 | The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. The number of participants with positive ADA was reported. |
| Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline, Week 8, 16, 24, 40, 48, 64 and 156 | The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (\>=) 0.903. The number of participants with NAb was reported. Here inconclusive refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, United States
Participant flow
Recruitment details
The study was conducted at 101 centers in 21 countries between 18 Mar 2013 (first participant first visit) and 13 Dec 2017 (last participant last visit).
Pre-assignment details
A total of 331 participants were randomized and 330 participants received treatment in the study. One participant discontinued due to adverse event prior to receiving treatment.
Participants by arm
| Arm | Count |
|---|---|
| SHP647 75 mg Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. | 164 |
| SHP647 225 mg Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. | 166 |
| Total | 330 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 12 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Other (Insufficient clinical response) | 22 | 20 |
| Overall Study | Other (other) | 9 | 5 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | Withdrawal by Subject | 34 | 42 |
Baseline characteristics
| Characteristic | SHP647 225 mg | Total | SHP647 75 mg |
|---|---|---|---|
| Age, Continuous | 41.1 Years STANDARD_DEVIATION 13.68 | 40.8 Years STANDARD_DEVIATION 13.21 | 40.5 Years STANDARD_DEVIATION 12.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 160 Participants | 320 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 15 Participants | 26 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Race More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants | 8 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 143 Participants | 291 Participants | 148 Participants |
| Sex: Female, Male Female | 70 Participants | 132 Participants | 62 Participants |
| Sex: Female, Male Male | 96 Participants | 198 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 164 | 0 / 166 |
| other Total, other adverse events | 116 / 164 | 119 / 166 |
| serious Total, serious adverse events | 34 / 164 | 40 / 166 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
Time frame: From start of study drug administration up to 168 weeks
Population: SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHP647 75 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Participants with any TEAE | 146 Participants |
| SHP647 75 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Participants with any TESAE | 34 Participants |
| SHP647 75 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Participants who withdrew treatment due to TEAE | 12 Participants |
| SHP647 225 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Participants with any TEAE | 147 Participants |
| SHP647 225 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Participants with any TESAE | 40 Participants |
| SHP647 225 mg | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs) | Participants who withdrew treatment due to TEAE | 23 Participants |
Secondary
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64. The number of participants with positive ADA was reported.
Time frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Population: The SAS consisted of all enrolled participants who had received at least 1 dose of SHP647. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Baseline | 9 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 40 | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 16 | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 48 | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 8 | 3 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 64 | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 156 | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 24 | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 156 | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Baseline | 10 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 8 | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 16 | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 24 | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 40 | 2 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 48 | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA) | Week 64 | 0 Participants |
Secondary
Number of Participants With Positive Neutralizing Antibodies (NAb)
The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (\>=) 0.903. The number of participants with NAb was reported. Here inconclusive refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (\>=) 4.64.
Time frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Population: Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specific time points with non-missing ADA sample.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 8: With +ADA, with +NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, with +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, without +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, with inconclusive NAb | 8 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, missing NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 8: Without +ADA | 140 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: Without +ADA | 139 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 8: With +ADA, without +NAb | 2 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 16: Without +ADA | 139 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 16: With +ADA, with +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 16: With +ADA, without +NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 24: Without +ADA | 105 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 24: With +ADA, with +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 24: With +ADA, without +NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 40: Without +ADA | 93 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 40: With +ADA, with +NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 40: With +ADA, without +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 48: Without +ADA | 96 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 48: With +ADA, with +NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 48: With +ADA, without +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 64: Without +ADA | 82 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 64: With +ADA, with +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 64: With +ADA, without +NAb | 1 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 156: Without +ADA | 73 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 156: With +ADA, with +NAb | 0 Participants |
| SHP647 75 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 156: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 48: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: Without +ADA | 143 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 24: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, with +NAb | 4 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 156: With +ADA, with +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, without +NAb | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 40: Without +ADA | 102 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, with inconclusive NAb | 5 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 64: Without +ADA | 86 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Baseline: With +ADA, missing NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 40: With +ADA, with +NAb | 2 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 8: Without +ADA | 150 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 156: Without +ADA | 80 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 8: With +ADA, with +NAb | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 40: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 8: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 64: With +ADA, with +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 16: Without +ADA | 143 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 48: Without +ADA | 92 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 16: With +ADA, with +NAb | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 156: With +ADA, without +NAb | 1 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 16: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 48: With +ADA, with +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 24: Without +ADA | 118 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 64: With +ADA, without +NAb | 0 Participants |
| SHP647 225 mg | Number of Participants With Positive Neutralizing Antibodies (NAb) | Week 24: With +ADA, with +NAb | 1 Participants |
Secondary
Percentage of Participants With Mucosal Healing at Week 16
Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment \[PGA\]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Time frame: Week 16
Population: SAS consisted of all enrolled participants who had received at least 1 dose of SHP647.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SHP647 75 mg | Percentage of Participants With Mucosal Healing at Week 16 | 27.4 Percentage of participants |
| SHP647 225 mg | Percentage of Participants With Mucosal Healing at Week 16 | 29.5 Percentage of participants |
Secondary
Serum Trough Concentrations of SHP647 Versus Time
Serum trough concentrations of SHP647 versus time was reported.
Time frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Population: The pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of SHP647 and for whom at least 1 postdose PK sample was collected. Here 'Number of Participants Analyzed' refers to the number of participants evaluable for specific timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Baseline | 6398.62 Micrograms/liter (ug/L) | Standard Deviation 8584.412 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 4 | 5496.56 Micrograms/liter (ug/L) | Standard Deviation 4026.759 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 8 | 6245.79 Micrograms/liter (ug/L) | Standard Deviation 3371.708 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 12 | 9038.72 Micrograms/liter (ug/L) | Standard Deviation 5540.836 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 16 | 10445.24 Micrograms/liter (ug/L) | Standard Deviation 6387.004 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 20 | 10928.76 Micrograms/liter (ug/L) | Standard Deviation 7900.859 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 24 | 11145.54 Micrograms/liter (ug/L) | Standard Deviation 8019.864 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 28 | 12978.11 Micrograms/liter (ug/L) | Standard Deviation 8772.285 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 32 | 12926.04 Micrograms/liter (ug/L) | Standard Deviation 8798.671 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 36 | 12785.55 Micrograms/liter (ug/L) | Standard Deviation 9182.501 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 40 | 13004.90 Micrograms/liter (ug/L) | Standard Deviation 9544.675 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 44 | 13337.50 Micrograms/liter (ug/L) | Standard Deviation 8620.549 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 48 | 14061.44 Micrograms/liter (ug/L) | Standard Deviation 9257.991 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 52 | 14192.83 Micrograms/liter (ug/L) | Standard Deviation 9326.176 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 56 | 15179.77 Micrograms/liter (ug/L) | Standard Deviation 10405.996 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 60 | 15133.54 Micrograms/liter (ug/L) | Standard Deviation 9673.602 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 64 | 15354.29 Micrograms/liter (ug/L) | Standard Deviation 10112.098 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 68 | 15584.38 Micrograms/liter (ug/L) | Standard Deviation 10407.781 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 72 | 15006.48 Micrograms/liter (ug/L) | Standard Deviation 9390.02 |
| SHP647 75 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 156 | 983.49 Micrograms/liter (ug/L) | Standard Deviation 1485.708 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 68 | 30609.08 Micrograms/liter (ug/L) | Standard Deviation 14331.857 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Baseline | 8064.41 Micrograms/liter (ug/L) | Standard Deviation 10629.768 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 40 | 28947.34 Micrograms/liter (ug/L) | Standard Deviation 12151.971 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 4 | 16787.31 Micrograms/liter (ug/L) | Standard Deviation 7807.292 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 60 | 29086.78 Micrograms/liter (ug/L) | Standard Deviation 12606.888 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 8 | 20345.29 Micrograms/liter (ug/L) | Standard Deviation 9286.956 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 44 | 29855.69 Micrograms/liter (ug/L) | Standard Deviation 13605.897 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 12 | 23915.87 Micrograms/liter (ug/L) | Standard Deviation 10434.073 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 156 | 1893.88 Micrograms/liter (ug/L) | Standard Deviation 4530.68 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 16 | 24772.35 Micrograms/liter (ug/L) | Standard Deviation 11970.153 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 48 | 30010.61 Micrograms/liter (ug/L) | Standard Deviation 14014.183 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 20 | 25582.98 Micrograms/liter (ug/L) | Standard Deviation 11767.775 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 64 | 31613.08 Micrograms/liter (ug/L) | Standard Deviation 13712.478 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 24 | 27832.20 Micrograms/liter (ug/L) | Standard Deviation 12469.086 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 52 | 28917.76 Micrograms/liter (ug/L) | Standard Deviation 14545.617 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 28 | 27797.77 Micrograms/liter (ug/L) | Standard Deviation 13070.361 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 72 | 31342.89 Micrograms/liter (ug/L) | Standard Deviation 14012.311 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 32 | 28381.93 Micrograms/liter (ug/L) | Standard Deviation 11748.573 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 56 | 29985.88 Micrograms/liter (ug/L) | Standard Deviation 14122.172 |
| SHP647 225 mg | Serum Trough Concentrations of SHP647 Versus Time | Week 36 | 29666.64 Micrograms/liter (ug/L) | Standard Deviation 13997.231 |