Trial Outcomes & Findings for A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED) (NCT NCT00732875)
NCT ID: NCT00732875
Last Updated: 2017-04-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
92 participants
Primary outcome timeframe
throughout entire study (61 +/- 28.9 weeks on average)
Results posted on
2017-04-13
Participant Flow
Subjects showing clinical response at Week 30 of a previous double-blind study of infliximab vs placebo (P04280,NCT00202852) were eligible for this study. A total of 105 subjects were eligible (67 from previous placebo \& 38 from previous infliximab group) for this extension study, among whom a total of 92 enrolled to participate in the extension.
Of the 92 enrolled subjects, 61 were from the placebo group and 31 from the infliximab group of the previous study.
Participant milestones
| Measure |
Open Label Infliximab + Methotrexate
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Overall Study
STARTED
|
92
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
35
|
Reasons for withdrawal
| Measure |
Open Label Infliximab + Methotrexate
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Overall Study
Adverse Event
|
16
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Lack of Efficacy
|
13
|
Baseline Characteristics
A Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Korean Patients With Active Rheumatoid Arthritis Despite Methorexate (Extension Part)(Study P05645)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Open Label Infliximab + Methotrexate
n=92 Participants
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Age, Continuous
|
50.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Age, Customized
<30 years
|
2 participants
n=5 Participants
|
|
Age, Customized
Between 30 and less than 40 years
|
14 participants
n=5 Participants
|
|
Age, Customized
Between 40 and less than 50 years
|
29 participants
n=5 Participants
|
|
Age, Customized
Between 50 and less than 60 years
|
29 participants
n=5 Participants
|
|
Age, Customized
Between 60 and less than 70 years
|
15 participants
n=5 Participants
|
|
Age, Customized
>=70 years
|
3 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: throughout entire study (61 +/- 28.9 weeks on average)Population: All participants were included regardless of how long they stayed in the study.
Outcome measures
| Measure |
Open Label Infliximab + Methotrexate
n=92 Participants
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Number of Subjects Experiencing Any Adverse Event
|
76 participants
|
PRIMARY outcome
Timeframe: throughout entire study (61 +/- 28.9 weeks on average)Population: All participants were included regardless of how long they stayed in the study.
Serious adverse events are defined as death, life-threatening events, persistent or significant disability/incapacity, hospitalization or prolongation of hospitalization and congenital anomalies.
Outcome measures
| Measure |
Open Label Infliximab + Methotrexate
n=92 Participants
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Number of Subjects Experiencing Serious Adverse Event
|
12 participants
|
PRIMARY outcome
Timeframe: throughout entire study (61 +/- 28.9 weeks on average)Population: All participants were included regardless of how long they stayed in the study
Outcome measures
| Measure |
Open Label Infliximab + Methotrexate
n=92 Participants
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Number of Subjects Experiencing Any Infection
|
41 participants
|
Adverse Events
Open Label Infliximab + Methotrexate
Serious events: 12 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Infliximab + Methotrexate
n=92 participants at risk
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Gastrointestinal disorders
gastric ulcer
|
1.1%
1/92 • Number of events 2
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
General disorders
chest discomfort
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
General disorders
inflammation
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
General disorders
infusion related reaction
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
General disorders
ulcer
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Hepatobiliary disorders
cholecystitis acute
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Immune system disorders
anaphylactoid reaction
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Infections and infestations
chronic sinusitis
|
2.2%
2/92 • Number of events 2
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Infections and infestations
pneumonia cryptococcal
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Infections and infestations
pyelonephritis acute
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Injury, poisoning and procedural complications
thoracic vertebral fracture
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.2%
2/92 • Number of events 2
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Psychiatric disorders
confusional state
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal discomfort
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis hypertrophic
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
2.2%
2/92 • Number of events 2
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Vascular disorders
flushing
|
1.1%
1/92 • Number of events 1
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
Other adverse events
| Measure |
Open Label Infliximab + Methotrexate
n=92 participants at risk
Open label Infliximab infusions at weeks 0, 2, and 6 and every 8 weeks + methotrexate (MTX)
|
|---|---|
|
Gastrointestinal disorders
diarrhoea
|
5.4%
5/92 • Number of events 6
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Gastrointestinal disorders
nausea
|
8.7%
8/92 • Number of events 11
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Gastrointestinal disorders
vomiting
|
5.4%
5/92 • Number of events 5
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
General disorders
chills
|
6.5%
6/92 • Number of events 8
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Infections and infestations
nasopharyngitis
|
6.5%
6/92 • Number of events 6
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Infections and infestations
upper respiratory tract infection
|
20.7%
19/92 • Number of events 27
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Investigations
alanine aminotransferase increased
|
6.5%
6/92 • Number of events 7
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Investigations
aspartate aminotransferase increased
|
5.4%
5/92 • Number of events 6
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Nervous system disorders
headache
|
8.7%
8/92 • Number of events 9
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.5%
6/92 • Number of events 7
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
5.4%
5/92 • Number of events 7
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
12.0%
11/92 • Number of events 13
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
|
Skin and subcutaneous tissue disorders
urticaria
|
9.8%
9/92 • Number of events 13
During conduct of the trial, adverse events were summarized using WHOART dictionary terms. Adverse events were recoded to MedDRA terms for this section of the results display.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All proposed publications/presentations by the investigators or their personnel/associates resulting from/relating to this study must be submitted to SP Korea for review and approval before submission for publication/presentation. If the proposed publication/presentation contains patentable subject matter, which, at SP Korea's sole discretion, warrants intellectual property protection, SP Korea may delay any publication or presentation for the purpose of pursuing such protection.
- Publication restrictions are in place
Restriction type: OTHER