Trial Outcomes & Findings for A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis (NCT NCT00287118)
NCT ID: NCT00287118
Last Updated: 2018-04-03
Results Overview
The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
189 participants
Primary outcome timeframe
Week 24
Results posted on
2018-04-03
Participant Flow
Participant milestones
| Measure |
Efalizumab
Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
|
|---|---|
|
Overall Study
STARTED
|
189
|
|
Overall Study
COMPLETED
|
137
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
| Measure |
Efalizumab
Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
30
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Other
|
7
|
Baseline Characteristics
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Efalizumab
n=189 Participants
Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
|
|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Intent to Treat (ITT) population consisted of all subjects who received at least 1 dose of trial medication.
The PGA rating was used to assess the global response of all psoriatic lesions by comparing subject's present condition to baseline photographs or body diagrams. The response was classified as Cleared: 100% improvement of all clinical signs and symptoms compared to baseline; Excellent: 75% to 99% improvement of all signs and symptoms compared to baseline; Good: 50% to 74% improvement of signs and symptoms compared to baseline; Fair: 25% to 49% improvement of signs and symptoms compared to baseline; Slight: 1% to 24% improvement of signs and symptoms compared to baseline; Unchanged: Clinical signs and symptoms unchanged from baseline and Worse: Clinical signs and symptoms deteriorated from baseline.
Outcome measures
| Measure |
Efalizumab
n=189 Participants
Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
|
|---|---|
|
Percentage of Subjects With Physician's Global Assessment (PGA) Ratings of "Excellent" or "Cleared" at Week 24
|
46.0 percentage of subjects
Interval 38.9 to 53.1
|
Adverse Events
Efalizumab
Serious events: 21 serious events
Other events: 161 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Efalizumab
n=189 participants at risk
Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
3.7%
7/189
|
|
Skin and subcutaneous tissue disorders
Nail psoriasis
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.6%
3/189
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
2/189
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
2/189
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.53%
1/189
|
|
Infections and infestations
Cytomegalovirus infection
|
0.53%
1/189
|
|
Infections and infestations
Meningitis aseptic
|
0.53%
1/189
|
|
Infections and infestations
Pneumonia
|
0.53%
1/189
|
|
Infections and infestations
Sepsis
|
0.53%
1/189
|
|
Infections and infestations
Tooth abscess
|
0.53%
1/189
|
|
Investigations
Hepatic enzyme increased
|
0.53%
1/189
|
|
Investigations
Prostatic specific antigen increased
|
0.53%
1/189
|
|
Cardiac disorders
Tachyarrhythmia
|
0.53%
1/189
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.53%
1/189
|
|
General disorders
Pyrexia
|
0.53%
1/189
|
|
Hepatobiliary disorders
Cholecystitis
|
0.53%
1/189
|
|
Injury, poisoning and procedural complications
Lumbar puncture headache
|
0.53%
1/189
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.53%
1/189
|
|
Nervous system disorders
Intracranial aneurysm
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.53%
1/189
|
Other adverse events
| Measure |
Efalizumab
n=189 participants at risk
Subjects received a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
|
|---|---|
|
Nervous system disorders
Headache
|
36.0%
68/189
|
|
Nervous system disorders
Dizziness
|
5.3%
10/189
|
|
Nervous system disorders
Somnolence
|
3.2%
6/189
|
|
Nervous system disorders
Syncope
|
1.1%
2/189
|
|
Nervous system disorders
Burning sensation
|
0.53%
1/189
|
|
Nervous system disorders
Dysgeusia
|
0.53%
1/189
|
|
Nervous system disorders
Syncope vasovagal
|
0.53%
1/189
|
|
Nervous system disorders
Tremor
|
0.53%
1/189
|
|
General disorders
Influenza like illness
|
11.6%
22/189
|
|
General disorders
Pyrexia
|
11.1%
21/189
|
|
General disorders
Chills
|
9.5%
18/189
|
|
General disorders
Feeling hot
|
3.2%
6/189
|
|
General disorders
Oedema peripheral
|
3.2%
6/189
|
|
General disorders
Chest pain
|
2.1%
4/189
|
|
General disorders
Asthenia
|
1.6%
3/189
|
|
General disorders
Fatigue
|
1.6%
3/189
|
|
General disorders
Malaise
|
1.1%
2/189
|
|
General disorders
Oedema
|
1.1%
2/189
|
|
General disorders
Pain
|
1.1%
2/189
|
|
General disorders
Feeling cold
|
0.53%
1/189
|
|
General disorders
Hyperthermia
|
0.53%
1/189
|
|
General disorders
Injection site irritation
|
0.53%
1/189
|
|
General disorders
Injection site pain
|
0.53%
1/189
|
|
General disorders
Prostration
|
0.53%
1/189
|
|
General disorders
Thirst
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.7%
24/189
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.7%
24/189
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
17/189
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.2%
8/189
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
8/189
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
1.6%
3/189
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Dactylitis
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Intervertebral discitis
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.53%
1/189
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.53%
1/189
|
|
Infections and infestations
Influenza
|
6.9%
13/189
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
6/189
|
|
Infections and infestations
Herpes simplex
|
2.1%
4/189
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
4/189
|
|
Infections and infestations
Onychomycosis
|
1.6%
3/189
|
|
Infections and infestations
Pneumonia
|
1.1%
2/189
|
|
Infections and infestations
Sinusitis
|
1.6%
3/189
|
|
Infections and infestations
Urinary tract infection
|
1.6%
3/189
|
|
Infections and infestations
Bronchitis
|
1.1%
2/189
|
|
Infections and infestations
Gastroenteritis
|
1.1%
2/189
|
|
Infections and infestations
Tonsillitis
|
1.1%
2/189
|
|
Infections and infestations
Acarodermatitis
|
0.53%
1/189
|
|
Infections and infestations
Body tinea
|
0.53%
1/189
|
|
Infections and infestations
Condyloma acuminatum
|
0.53%
1/189
|
|
Infections and infestations
Cystitis
|
0.53%
1/189
|
|
Infections and infestations
Dental caries
|
0.53%
1/189
|
|
Infections and infestations
Dermatophytosis
|
0.53%
1/189
|
|
Infections and infestations
Enteritis infectious
|
0.53%
1/189
|
|
Infections and infestations
Folliculitis
|
0.53%
1/189
|
|
Infections and infestations
Furuncle
|
0.53%
1/189
|
|
Infections and infestations
Hordeolum
|
0.53%
1/189
|
|
Infections and infestations
Impetigo
|
0.53%
1/189
|
|
Infections and infestations
Nail candida
|
0.53%
1/189
|
|
Infections and infestations
Perineal abscess
|
0.53%
1/189
|
|
Infections and infestations
Pharyngotonsillitis
|
0.53%
1/189
|
|
Infections and infestations
Rash pustular
|
0.53%
1/189
|
|
Infections and infestations
Rhinitis
|
0.53%
1/189
|
|
Infections and infestations
Skin bacterial infection
|
0.53%
1/189
|
|
Infections and infestations
Tinea pedis
|
0.53%
1/189
|
|
Infections and infestations
Tinea versicolour
|
0.53%
1/189
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.53%
1/189
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
14/189
|
|
Gastrointestinal disorders
Nausea
|
7.4%
14/189
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
6/189
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
6/189
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
3/189
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
3/189
|
|
Gastrointestinal disorders
Toothache
|
1.6%
3/189
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
2/189
|
|
Gastrointestinal disorders
Flatulence
|
1.1%
2/189
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
1.1%
2/189
|
|
Gastrointestinal disorders
Abdominal distension
|
0.53%
1/189
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.53%
1/189
|
|
Gastrointestinal disorders
Constipation
|
0.53%
1/189
|
|
Gastrointestinal disorders
Gingivitis
|
0.53%
1/189
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.53%
1/189
|
|
Gastrointestinal disorders
Odynophagia
|
0.53%
1/189
|
|
Gastrointestinal disorders
Stomatitis
|
0.53%
1/189
|
|
Gastrointestinal disorders
Tooth disorder
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.3%
10/189
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.8%
11/189
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.1%
2/189
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.1%
2/189
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.1%
2/189
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.1%
2/189
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.53%
1/189
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.53%
1/189
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
8/189
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.1%
4/189
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
1.1%
2/189
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.53%
1/189
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.53%
1/189
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.53%
1/189
|
|
Blood and lymphatic system disorders
Leukocytosis
|
3.2%
6/189
|
|
Blood and lymphatic system disorders
Eosinophilia
|
1.1%
2/189
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
2/189
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
1.1%
2/189
|
|
Blood and lymphatic system disorders
Anaemia
|
0.53%
1/189
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.53%
1/189
|
|
Blood and lymphatic system disorders
Thrombocythaemia
|
0.53%
1/189
|
|
Investigations
Blood creatine phosphokinase increased
|
1.1%
2/189
|
|
Investigations
Blood creatinine increased
|
0.53%
1/189
|
|
Investigations
Blood glucose increased
|
0.53%
1/189
|
|
Investigations
Blood phosphorus increased
|
0.53%
1/189
|
|
Investigations
Blood pressure increased
|
0.53%
1/189
|
|
Investigations
Blood uric acid increased
|
0.53%
1/189
|
|
Investigations
Culture throat positive
|
0.53%
1/189
|
|
Investigations
Liver function test abnormal
|
0.53%
1/189
|
|
Investigations
Neutrophil count increased
|
0.53%
1/189
|
|
Investigations
Weight decreased
|
0.53%
1/189
|
|
Vascular disorders
Hypertension
|
4.8%
9/189
|
|
Vascular disorders
Peripheral occlusive disease
|
0.53%
1/189
|
|
Vascular disorders
Phlebitis
|
0.53%
1/189
|
|
Eye disorders
Conjunctivitis
|
1.1%
2/189
|
|
Eye disorders
Eye pain
|
1.1%
2/189
|
|
Eye disorders
Blepharitis
|
0.53%
1/189
|
|
Eye disorders
Blepharospasm
|
0.53%
1/189
|
|
Eye disorders
Conjunctival hyperaemia
|
0.53%
1/189
|
|
Eye disorders
Eye irritation
|
0.53%
1/189
|
|
Eye disorders
Growth of eyelashes
|
0.53%
1/189
|
|
Eye disorders
Lacrimation increased
|
0.53%
1/189
|
|
Eye disorders
Ocular hyperaemia
|
0.53%
1/189
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.6%
3/189
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.6%
3/189
|
|
Metabolism and nutrition disorders
Anorexia
|
1.1%
2/189
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.53%
1/189
|
|
Metabolism and nutrition disorders
Gout
|
0.53%
1/189
|
|
Ear and labyrinth disorders
Ear pain
|
2.1%
4/189
|
|
Ear and labyrinth disorders
Deafness
|
0.53%
1/189
|
|
Ear and labyrinth disorders
Tinnitus
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Genital discharge
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.53%
1/189
|
|
Reproductive system and breast disorders
Vaginal disorder
|
0.53%
1/189
|
|
Psychiatric disorders
Depression
|
1.1%
2/189
|
|
Psychiatric disorders
Insomnia
|
1.1%
2/189
|
|
Psychiatric disorders
Stress
|
0.53%
1/189
|
|
Renal and urinary disorders
Dysuria
|
1.6%
3/189
|
|
Renal and urinary disorders
Leukocyturia
|
0.53%
1/189
|
|
Renal and urinary disorders
Nephritis
|
0.53%
1/189
|
|
Renal and urinary disorders
Polyuria
|
0.53%
1/189
|
|
Cardiac disorders
Angina pectoris
|
0.53%
1/189
|
|
Cardiac disorders
Palpitations
|
0.53%
1/189
|
|
Cardiac disorders
Tachycardia
|
0.53%
1/189
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.53%
1/189
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.53%
1/189
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.53%
1/189
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraproteinaemia
|
0.53%
1/189
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.53%
1/189
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.53%
1/189
|
Additional Information
Merck KGaA Communication Center
Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER