Trial Outcomes & Findings for Safety and Efficacy of Infliximab in Palmoplantar Psoriasis (NCT NCT00629772)

NCT ID: NCT00629772

Last Updated: 2011-09-09

Results Overview

Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole). Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 24 participants
• Primary outcome timeframe: 14 weeks
• Results posted on: 2011-09-09

Participant Flow

Participant milestones

Measure	Placebo Then Infliximab Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
First Intervention - Day 0 - Week 14 STARTED	12	12
First Intervention - Day 0 - Week 14 COMPLETED	12	12
First Intervention - Day 0 - Week 14 NOT COMPLETED	0	0
Second Intervention Week 14 - Week 26 STARTED	12	12
Second Intervention Week 14 - Week 26 COMPLETED	11	10
Second Intervention Week 14 - Week 26 NOT COMPLETED	1	2

Reasons for withdrawal

Measure	Placebo Then Infliximab Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Second Intervention Week 14 - Week 26 Adverse Event	1	1
Second Intervention Week 14 - Week 26 Lack of Efficacy	0	1

Baseline Characteristics

Safety and Efficacy of Infliximab in Palmoplantar Psoriasis

Baseline characteristics by cohort

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab n=12 Participants Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age Continuous	49.92 years STANDARD_DEVIATION 14.74 • n=5 Participants	57.83 years STANDARD_DEVIATION 12.42 • n=7 Participants	53.87 years STANDARD_DEVIATION 13.92 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Canada	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI)	26.7 Units on a scale STANDARD_DEVIATION 12.4 • n=5 Participants	24.1 Units on a scale STANDARD_DEVIATION 11.4 • n=7 Participants	25.4 Units on a scale STANDARD_DEVIATION 11.7 • n=5 Participants
Dermatology Life Quality Index (DLQI)	11.9 Units on a scale STANDARD_DEVIATION 6.9 • n=5 Participants	9.8 Units on a scale STANDARD_DEVIATION 4.4 • n=7 Participants	10.8 Units on a scale STANDARD_DEVIATION 5.8 • n=5 Participants
Physician's Global Assessment (PGA)	3.8 Units on as scale STANDARD_DEVIATION 0.6 • n=5 Participants	3.5 Units on as scale STANDARD_DEVIATION 0.7 • n=7 Participants	3.7 Units on as scale STANDARD_DEVIATION 0.6 • n=5 Participants
Palmoplantar Psoriasis Surface Area PPSA	40.4 Percentage of affected area STANDARD_DEVIATION 21.6 • n=5 Participants	37.1 Percentage of affected area STANDARD_DEVIATION 21.0 • n=7 Participants	38.8 Percentage of affected area STANDARD_DEVIATION 20.9 • n=5 Participants

PRIMARY outcome

Timeframe: 14 weeks

Population: The analysis was performed on the intent to treat (ITT) population. Nonresponder imputation (NRI) was used for patients who withdrew before the end of the study. They were treated as nonresponders from the point of withdrawal onward.

Efficacy by comparing the number of patients reaching a 75% improvement in m-PPPASI (m-PPPASI 75) m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).

Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab n=12 Participants Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
75% Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) From Day 0	1 Participants	4 Participants

SECONDARY outcome

Timeframe: 14 weeks

Safety of infliximab administered for 14 weeks in patients who received by comparing adverse events

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab n=12 Participants Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Number of Adverse Events at Week 14	20 Adverse Events	32 Adverse Events

SECONDARY outcome

Timeframe: 14 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Impact on quality of life with the Dermatology Life Quality Index (DLQI) The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.

• 0-1 = no effect at all on patient's life
• 2-5 = small effect on patient's life
• 6-10 = moderate effect on patient's life
• 11-20 = very large effect on patient's life
• 21-30 = extremely large effect on patient's life

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab n=12 Participants Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Dermatology Life Quality Index (DLQI) at Week 14	9.25 Units on a scale Standard Deviation 7.23	4.50 Units on a scale Standard Deviation 5.98

SECONDARY outcome

Timeframe: 14 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Efficacy by comparing the mean percent PPSA. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles. A sole completely covered with psoriasis would have a PPSA of 30% (if the other sole and the palms are unaffected) while a palm completely covered with psoriasis would have a PPSA of 20% (if the other palm and the soles are unaffected).

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab n=12 Participants Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) at Week 14	38.58 Percentage of affected area Standard Deviation 20.6	17.23 Percentage of affected area Standard Deviation 15.75

SECONDARY outcome

Timeframe: 14 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Efficacy by comparing the mean Physician's Global Assessment(PGA).

• 0 = clear.
• 1 = almost clear.
• 2 = Mild.
• 3 = Moderate.
• 4 = Severe.
• 5 = Very severe.

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab n=12 Participants Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Physician's Global Assessment (PGA) at Week 14	3.33 Units on a scale Standard Deviation 1.37	2 Units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Baseline, 26 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in modified m-PPPASI from Day 0 to Week 26.

m-PPPASI = (E + I + D)Area X 0.2 (R palm) + (E + I + D) Area X 0.2 (L palm) + (E + I + D) Area X 0.3 (R sole) + (E + I + D) Area X 0.3 (L sole).

Erythema, induration and desquamation are evaluated on a scale of 0 to 4 while area is evaluated on a scale of 0 to 6. The m-PPPASI score can vary from 0 (absence of disease) to 72 (most severe palmoplantar psoriasis possible).

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Percent Improvement in Modified Palmoplantar Pustulosis Area and Severity Index (m-PPPASI) at Week 26	71.81 Percent improvement Standard Deviation 31.59	—

SECONDARY outcome

Timeframe: Baseline, 26 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in dermatology life quality index (DLQI) from Day 0 to Week 26.

Impact on quality of life with the DLQI. The aim of the questionnaire is to measure how much a patient's skin problem has affected their life over the previous week.

• 0-1 = no effect at all on patient's life
• 2-5 = small effect on patient's life
• 6-10 = moderate effect on patient's life
• 11-20 = very large effect on patient's life
• 21-30 = extremely large effect on patient's life

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Percent Improvement in Dermatology Life Quality Index (DLQI) at Week 26	63.45 Percent improvement Standard Deviation 30.29	—

SECONDARY outcome

Timeframe: Baseline, 26 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in Physician's Global Assessment (PGA) from Day 0 to Week 26.

• 0 = clear
• 1 = almost clear
• 2 = Mild
• 3 = Moderate
• 4 = Severe
• 5 = Very severe

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Percent Improvement in Physician's Global Assessment (PGA) at Week 26	47.92 Percent improvement Standard Deviation 41.76	—

SECONDARY outcome

Timeframe: Baseline, 26 weeks

Population: The analysis was performed on the intent to treat (ITT) population and the imputation technique was last observation carried forward (LOCF).

Efficacy of infliximab administered for 22 weeks in patients who received infliximab at Day 0 by evaluating the improvement over time in percent PPSA from Day 0 to Week 26. The surface affected by psoriasis on palms and soles is estimated on the day of the visit as a percentage of the total surface of palms and soles affected by psoriasis. Each palm represents 20% and each sole 30%. As a rule of thumb half a palm equals 10% of the total surface area of palm and soles.

Outcome measures

Measure	Placebo Then Infliximab n=12 Participants Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.	Infliximab Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22.
Mean Percent Improvement in Palmoplantar Psoriasis Surface Area (PPSA) at Week 26	65.91 Percent improvement Standard Deviation 38.91	—

Adverse Events

Infliximab

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Then Infliximab

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infliximab n=12 participants at risk Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.	Placebo Then Infliximab n=12 participants at risk Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
Infections and infestations Cellulitis Right Cheek	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Hepatobiliary disorders Hepatitis	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Sternum Fracture	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.

Other adverse events

Measure	Infliximab n=12 participants at risk Infliximab 5mg/kg at weeks 0, 2, 6, 14 and 22 throughout the entire study.	Placebo Then Infliximab n=12 participants at risk Placebo at weeks 0, 2, 8 during the first intervention period and infliximab 5mg/kg at weeks 14, 16 and 20 during second intervention period.
Gastrointestinal disorders Abdominal pain	8.3% 1/12 • Number of events 3 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	25.0% 3/12 • Number of events 4 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Bronchitis	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 2 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Injury, poisoning and procedural complications Burn right arm	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Nervous system disorders Burning sensation to feet	8.3% 1/12 • Number of events 3 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Cellulitis Right Elbow	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Cervical pain	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Common cold	25.0% 3/12 • Number of events 3 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	25.0% 3/12 • Number of events 4 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Injury, poisoning and procedural complications Costal ribs fracture	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Cystitis	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Skin and subcutaneous tissue disorders Dermatitis	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Nervous system disorders Dizziness	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Skin and subcutaneous tissue disorders Erythema right forearm and both thighs	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Vascular disorders Facial flushing	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 2 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
General disorders Fatigue	16.7% 2/12 • Number of events 3 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Skin and subcutaneous tissue disorders Feet Oedema	8.3% 1/12 • Number of events 3 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Ganglion	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
General disorders Hair Loss	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Nervous system disorders Headache	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammed Seborrheic Keratosis	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Influenza	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Joint pain in hand	16.7% 2/12 • Number of events 2 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Knee pain	8.3% 1/12 • Number of events 2 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Lower legs pain	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Gastrointestinal disorders Nausea	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Gastrointestinal disorders Oesophageal reflux with pyrosis	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Surgical and medical procedures Pain following dental surgery	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Pain in foot	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Musculoskeletal and connective tissue disorders Pain left shoulder	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Paronychia	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Skin and subcutaneous tissue disorders Pruritus right forearm and both thighs	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Respiratory, thoracic and mediastinal disorders Shortness of breath	8.3% 1/12 • Number of events 3 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Nervous system disorders Somnolence	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
General disorders Swelling left arm	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Injury, poisoning and procedural complications Tibia fracture	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Urinary tract infection	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Nervous system disorders Vagal reaction	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Infections and infestations Vaginal infection	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Gastrointestinal disorders Vomiting and Diarrhea	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Respiratory, thoracic and mediastinal disorders Worsening of asthma	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.
Vascular disorders Worsening of hypertension	8.3% 1/12 • Number of events 1 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.	0.00% 0/12 • Adverse events were collected for all patients after the informed consent form was signed until the end of the study at week 26. Patients randomized to placebo then infliximab did not receive infliximab prior to week 14.

Additional Information

Annie Levesque

Innovaderm Research

Phone: 514 521 4285

Email: alevesque@innovaderm.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60