Trial Outcomes & Findings for A Study To Monitor Long-Term Treatment With PF-00547659 (NCT NCT01298492)
NCT ID: NCT01298492
Last Updated: 2021-06-03
Results Overview
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
268 participants
Primary outcome timeframe
From start of study treatment up to Week 72 (Treatment Period)
Results posted on
2021-06-03
Participant Flow
The study was conducted at 81 centers in Austria, Belgium, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Republic of Korea, Serbia, Slovakia, South Africa, Spain and United States between 22 July 2011 (first participant first visit) and 27 July 2016 (last participant last visit).
A total of 268 participants (225 participants from Feeder Study A7281006 \[NCT01276509\] and 43 participants from Feeder Study A7281008 \[NCT01387594\]) were enrolled and overall 149 participants completed the study.
Participant milestones
| Measure |
PF-00547659 75 mg
Participants received PF-00547659 75 milligram (mg) subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Overall Study
STARTED
|
268
|
|
Overall Study
COMPLETED
|
149
|
|
Overall Study
NOT COMPLETED
|
119
|
Reasons for withdrawal
| Measure |
PF-00547659 75 mg
Participants received PF-00547659 75 milligram (mg) subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Insufficient Clinical Response
|
22
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Withdrawal by Subject
|
47
|
|
Overall Study
Other (Unspecified)
|
7
|
|
Overall Study
Withdrawn Due to Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Adverse Event(Related to Study Drug)
|
8
|
|
Overall Study
Adverse Event(Not Related to Study Drug)
|
18
|
Baseline Characteristics
A Study To Monitor Long-Term Treatment With PF-00547659
Baseline characteristics by cohort
| Measure |
PF-00547659 75 mg
n=268 Participants
Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Age, Continuous
|
36.5 year
STANDARD_DEVIATION 11.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From start of study treatment up to Week 72 (Treatment Period)Population: The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.
AEs included adverse drug reactions, illnesses with onset during the study, exacerbation of previous illnesses, clinically significant changes in physical examination findings and abnormal objective test findings (ECG, laboratory). An SAE was defined as any AE at any dose that resulted in death; was life threatening (immediate risk of death); required in-subject hospitalization or prolongation of existing hospitalization; resulted in a persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); or resulted in congenital anomaly/birth defect.
Outcome measures
| Measure |
PF-00547659 75 mg
n=268 Participants
Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Participants With SAEs
|
80 Participants
|
|
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Participants With AEs
|
249 Participants
|
|
Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)
Participants With AEs Led to Withdrawal
|
53 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 96Population: The modified intent-to-treat (mITT) population included all enrolled participants who received at least 1 dose of investigational product.
Positive Anti-Drug Antibodies result was defined as ADA titre value greater than or equal to (\>=) 4.64 at at least one of the time points.
Outcome measures
| Measure |
PF-00547659 75 mg
n=268 Participants
Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Number of Participants With Positive Anti-Drug (PF-00547659) Antibodies
|
63 Participants
|
SECONDARY outcome
Timeframe: Week 4,8,12,16,20,24,28,32,36,40,44,48,52,56,60,64,68,72,76,80,84,88,92,96Population: PK population included all enrolled participants who received at least 1 dose of investigational product and had data on at least 1 PK concentration.
Serum trough concentrations of PF-00547659 were analyzed using population Pharmacokinetic (PK) methodology.
Outcome measures
| Measure |
PF-00547659 75 mg
n=260 Participants
Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 68
|
14990 nanogram per milliliter (ng/mL)
Standard Deviation 12883
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 72
|
13910 nanogram per milliliter (ng/mL)
Standard Deviation 10554
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 76
|
10520 nanogram per milliliter (ng/mL)
Standard Deviation 10082
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 4
|
6673 nanogram per milliliter (ng/mL)
Standard Deviation 6634.2
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 8
|
6064 nanogram per milliliter (ng/mL)
Standard Deviation 4455.3
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 12
|
8040 nanogram per milliliter (ng/mL)
Standard Deviation 6293.1
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 16
|
9563 nanogram per milliliter (ng/mL)
Standard Deviation 7285.4
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 20
|
10400 nanogram per milliliter (ng/mL)
Standard Deviation 8438.6
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 24
|
10450 nanogram per milliliter (ng/mL)
Standard Deviation 7934.6
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 28
|
10780 nanogram per milliliter (ng/mL)
Standard Deviation 9211.0
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 32
|
11920 nanogram per milliliter (ng/mL)
Standard Deviation 10675
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 36
|
12460 nanogram per milliliter (ng/mL)
Standard Deviation 9717.1
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 40
|
12570 nanogram per milliliter (ng/mL)
Standard Deviation 10077
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 44
|
12960 nanogram per milliliter (ng/mL)
Standard Deviation 10999
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 48
|
13170 nanogram per milliliter (ng/mL)
Standard Deviation 11108
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 52
|
13560 nanogram per milliliter (ng/mL)
Standard Deviation 11388
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 56
|
13930 nanogram per milliliter (ng/mL)
Standard Deviation 11191
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 60
|
14130 nanogram per milliliter (ng/mL)
Standard Deviation 11095
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 64
|
14360 nanogram per milliliter (ng/mL)
Standard Deviation 11290
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 80
|
3555 nanogram per milliliter (ng/mL)
Standard Deviation 5339.8
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 84
|
1129 nanogram per milliliter (ng/mL)
Standard Deviation 2634.7
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 88
|
403.8 nanogram per milliliter (ng/mL)
Standard Deviation 1522.6
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 92
|
154.2 nanogram per milliliter (ng/mL)
Standard Deviation 1001.9
|
|
Serum Trough Concentrations of PF-00547659 Versus Time
Week 96
|
54.73 nanogram per milliliter (ng/mL)
Standard Deviation 487.07
|
Adverse Events
PF-00547659 75 mg
Serious events: 118 serious events
Other events: 206 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
PF-00547659 75 mg
n=268 participants at risk
Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Arthritis enteropathic
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Eye disorders
Visual impairment
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
3/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Anal fistula
|
2.6%
7/268 • Number of events 7 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Anal stenosis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Colitis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Crohn's disease
|
16.4%
44/268 • Number of events 51 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Duodenitis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Ileus
|
1.5%
4/268 • Number of events 4 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.75%
2/268 • Number of events 4 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Melaena
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.5%
4/268 • Number of events 11 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
General disorders
General physical health deterioration
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
General disorders
Pyrexia
|
0.75%
2/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Cardiac disorders
Coronary artery disease
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Cardiac disorders
Myocardial infarction
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Abdominal abscess
|
0.75%
2/268 • Number of events 2 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Abdominal wall abscess
|
0.75%
2/268 • Number of events 2 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Abscess intestinal
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Abscess neck
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Anal abscess
|
3.7%
10/268 • Number of events 10 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Clostridium difficile infection
|
1.1%
3/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Device related infection
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Gastroenteritis
|
1.1%
3/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Gastroenteritis viral
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Liver abscess
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Pelvic abscess
|
0.75%
2/268 • Number of events 2 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Perirectal abscess
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Peritonitis
|
1.1%
3/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Pneumonia
|
1.5%
4/268 • Number of events 5 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Postoperative abscess
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Rotavirus infection
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Splenic abscess
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Tonsillitis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Vulval abscess
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.75%
2/268 • Number of events 3 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Investigations
Blood creatine phosphokinase mm increased
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Investigations
Haematocrit decreased
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Renal and urinary disorders
Bladder dysfunction
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.75%
2/268 • Number of events 2 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Renal and urinary disorders
Urinoma
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.75%
2/268 • Number of events 2 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Nervous system disorders
Headache
|
0.75%
2/268 • Number of events 2 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Nervous system disorders
Intracranial venous sinus thrombosis
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Surgical and medical procedures
Benign breast lump removal
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Reproductive system and breast disorders
Perineal fistula
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.37%
1/268 • Number of events 1 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
Other adverse events
| Measure |
PF-00547659 75 mg
n=268 participants at risk
Participants received PF-00547659 75 mg subcutaneous injection once in every 4 weeks through Week 72. One time dose escalation to 225 mg subcutaneous injection was allowed after 8 weeks of the study for the participants who experienced clinical deterioration or unacceptably low level of response to study drug. One time dose de-escalation to 22.5 mg subcutaneous injection due to intolerance or AEs was also allowed after the investigator carefully assessed the status of the participant.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
31.0%
83/268 • Number of events 113 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.4%
28/268 • Number of events 30 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Abdominal pain
|
18.3%
49/268 • Number of events 59 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Anal fissure
|
5.2%
14/268 • Number of events 14 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.2%
14/268 • Number of events 18 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Crohn's disease
|
29.5%
79/268 • Number of events 111 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Diarrhoea
|
9.0%
24/268 • Number of events 38 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Nausea
|
11.9%
32/268 • Number of events 44 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
23/268 • Number of events 34 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
General disorders
Asthenia
|
5.6%
15/268 • Number of events 20 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
General disorders
Fatigue
|
7.5%
20/268 • Number of events 23 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
General disorders
Pyrexia
|
10.1%
27/268 • Number of events 36 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Anal abscess
|
5.2%
14/268 • Number of events 16 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Bronchitis
|
7.5%
20/268 • Number of events 26 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Gastroenteritis
|
7.1%
19/268 • Number of events 22 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Influenza
|
6.7%
18/268 • Number of events 19 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Nasopharyngitis
|
20.1%
54/268 • Number of events 93 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Pharyngitis
|
5.6%
15/268 • Number of events 18 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
20/268 • Number of events 25 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Infections and infestations
Urinary tract infection
|
7.1%
19/268 • Number of events 28 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
|
Nervous system disorders
Headache
|
13.1%
35/268 • Number of events 45 • From Start of Study Treatment up to Safety Follow up (Week 96)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right to review disclosures, requesting a delay of up to 60 days. The first publication must be a joint publication covering all centers. However, if a joint manuscript has not been submitted for publication within 12 months of completion or termination of study at all participating sites, Investigator may publish individual site results separately. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER