Trial Outcomes & Findings for A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250) (NCT NCT00705289)

Last Updated: 2015-07-30

Results Overview

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline age (see Baseline Characteristics) is reported in the statistical analysis.

Recruitment status

COMPLETED

Target enrollment

728 participants

Primary outcome timeframe

At Baseline

Results posted on

2015-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	RA Subjects/ Infliximab 3 mg/kg Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).
Overall Study STARTED	728
Overall Study COMPLETED	597
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	RA Subjects/ Infliximab 3 mg/kg Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).
Overall Study Subject or treating physician's choice	131

Baseline Characteristics

A Study to Observe Characteristics of Rheumatoid Arthritis in Patients Using Infliximab (Study P04250)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RA Subjects/ Infliximab 3 mg/kg n=728 Participants Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).
Age, Continuous	54.1 years STANDARD_DEVIATION 13.08 • n=5 Participants
Sex: Female, Male Female	571 Participants n=5 Participants
Sex: Female, Male Male	157 Participants n=5 Participants
Time since diagnosis	9.0 years STANDARD_DEVIATION 8.99 • n=5 Participants

PRIMARY outcome

Timeframe: At Baseline

Population: Efficacy evaluable population included all subjects who were enrolled and received at least one dose of study medication and with non-missing efficacy data at Baseline and at least one follow-up visit.

Outcome measures

Outcome measures
Measure	RA Subjects/ Infliximab 3 mg/kg n=662 Participants Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).	Male	Female	France	Germany	Greece	Italy	Netherlands	Norway	Poland	Portugal	Sweden
Baseline Raw Disease Activity Score for 28 Joint Swollen and Tender Joint Count (DAS28) by Age	5.2 Score on a scale Standard Deviation 1.15	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Baseline

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and time since diagnosis is reported in the statistical analysis.

Outcome measures

Outcome measures
Measure	RA Subjects/ Infliximab 3 mg/kg n=662 Participants Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).	Male	Female	France	Germany	Greece	Italy	Netherlands	Norway	Poland	Portugal	Sweden
Baseline Raw DAS28 by Time Since Diagnosis	5.2 Score on a scale Standard Deviation 1.15	—	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Baseline

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline gender (see Baseline Characteristics) is reported in the statistical analysis.

Outcome measures

Outcome measures
Measure	RA Subjects/ Infliximab 3 mg/kg n=662 Participants Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).	Male n=140 Participants	Female n=522 Participants	France	Germany	Greece	Italy	Netherlands	Norway	Poland	Portugal	Sweden
Baseline Raw DAS28 by Gender	5.2 Score on a scale Standard Deviation 1.15	5.23 Score on a scale Standard Deviation 1.11	5.19 Score on a scale Standard Deviation 1.16	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Baseline

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between Baseline Raw DAS28 and Baseline Characteristic is reported in the statistical analysis.

Outcome measures

Outcome measures
Measure	RA Subjects/ Infliximab 3 mg/kg n=55 Participants Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).	Male n=73 Participants	Female n=24 Participants	France n=104 Participants	Germany n=67 Participants	Greece n=78 Participants	Italy n=32 Participants	Netherlands n=17 Participants	Norway n=41 Participants	Poland n=51 Participants	Portugal n=20 Participants	Sweden n=100 Participants
Baseline Raw DAS28 by Country of Residence	5.38 Score on a scale Standard Deviation 0.90	5.43 Score on a scale Standard Deviation 1.22	4.57 Score on a scale Standard Deviation 1.16	4.97 Score on a scale Standard Deviation 1.12	5.38 Score on a scale Standard Deviation 1.23	5.15 Score on a scale Standard Deviation 1.14	5.03 Score on a scale Standard Deviation 1.05	5.07 Score on a scale Standard Deviation 1.23	5.39 Score on a scale Standard Deviation 1.13	5.83 Score on a scale Standard Deviation 0.87	5.08 Score on a scale Standard Deviation 1.48	4.96 Score on a scale Standard Deviation 1.09

PRIMARY outcome

Timeframe: At Baseline

Population: All efficacy evaluable subjects (n=662) included subjects with early RA not yet treated with anti-TNF (n=76), subjects with established RA not yet treated with anti-TNF (n=447), and subjects with RA who failed or did not tolerate another anti-TNF (n=123). Some subjects could not be classified into any subgroup due to missing diagnosis dates.

Results are reported as the mean DAS28 raw score at Baseline. DAS28 is a unit scale from 2.0 (best value) to 10.0 (worst value). The relationship between DAS28 and baseline characteristic is reported in the statistical analysis.

Outcome measures

Outcome measures
Measure	RA Subjects/ Infliximab 3 mg/kg n=662 Participants Subjects with rheumatoid arthritis (RA) in whom treatment with infliximab is started for the first time, in line with current clinical practice (and thus consistent with the European Summary of Product Characteristics \[SPC\] of Remicade®).	Male n=76 Participants	Female n=447 Participants	France n=123 Participants	Germany	Greece	Italy	Netherlands	Norway	Poland	Portugal	Sweden
Baseline Raw DAS28 by Previous Anti-Tumor Necrosis Factor (Anti-TNF) Therapy	5.2 Score on a scale Standard Deviation 1.15	5.3 Score on a scale Standard Deviation 1.16	5.2 Score on a scale Standard Deviation 1.14	5.3 Score on a scale Standard Deviation 1.16	—	—	—	—	—	—	—	—

Adverse Events

Infliximab 3 mg/kg

Serious events: 40 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infliximab 3 mg/kg n=721 participants at risk
Blood and lymphatic system disorders ANAEMIA	0.14% 1/721 • Number of events 1
Gastrointestinal disorders NAUSEA	0.14% 1/721 • Number of events 1
General disorders CHILLS	0.14% 1/721 • Number of events 1
General disorders GAIT DISTURBANCE	0.14% 1/721 • Number of events 1
General disorders HYPERTHERMIA	0.14% 1/721 • Number of events 1
General disorders INFUSION RELATED REACTION	0.28% 2/721 • Number of events 4
General disorders PYREXIA	0.14% 1/721 • Number of events 1
Hepatobiliary disorders CHOLECYSTITIS	0.28% 2/721 • Number of events 2
Immune system disorders HYPERSENSITIVITY	0.14% 1/721 • Number of events 1
Infections and infestations BRONCHOPNEUMONIA	0.14% 1/721 • Number of events 1
Infections and infestations CELLULITIS	0.14% 1/721 • Number of events 1
Infections and infestations DISSEMINATED TUBERCULOSIS	0.14% 1/721 • Number of events 1
Infections and infestations ERYSIPELAS	0.14% 1/721 • Number of events 1
Infections and infestations INFECTION	0.14% 1/721 • Number of events 1
Infections and infestations MASTITIS	0.14% 1/721 • Number of events 1
Infections and infestations PNEUMOCYSTIS JIROVECI PNEUMONIA	0.14% 1/721 • Number of events 1
Infections and infestations PNEUMONIA	0.28% 2/721 • Number of events 2
Infections and infestations PNEUMONIA LEGIONELLA	0.14% 1/721 • Number of events 1
Infections and infestations PYELONEPHRITIS	0.14% 1/721 • Number of events 1
Infections and infestations SALMONELLOSIS	0.14% 1/721 • Number of events 1
Infections and infestations URINARY TRACT INFECTION	0.14% 1/721 • Number of events 1
Injury, poisoning and procedural complications DEVICE FAILURE	0.14% 1/721 • Number of events 1
Injury, poisoning and procedural complications SYNOVIAL RUPTURE	0.14% 1/721 • Number of events 1
Investigations HEPATIC ENZYME INCREASED	0.14% 1/721 • Number of events 1
Investigations INVESTIGATION	0.14% 1/721 • Number of events 1
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.14% 1/721 • Number of events 1
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.14% 1/721 • Number of events 1
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.14% 1/721 • Number of events 1
Musculoskeletal and connective tissue disorders ARTHRITIS	0.14% 1/721 • Number of events 1
Musculoskeletal and connective tissue disorders RHEUMATOID ARTHRITIS	0.14% 1/721 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.14% 1/721 • Number of events 1
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL NEOPLASM	0.14% 1/721 • Number of events 1
Nervous system disorders SPEECH DISORDER	0.14% 1/721 • Number of events 1
Respiratory, thoracic and mediastinal disorders ALVEOLITIS	0.14% 1/721 • Number of events 1
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.14% 1/721 • Number of events 1
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.14% 1/721 • Number of events 1
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.14% 1/721 • Number of events 1
Social circumstances JOINT PROSTHESIS USER	0.14% 1/721 • Number of events 1
Surgical and medical procedures HERNIA REPAIR	0.14% 1/721 • Number of events 1
Vascular disorders HYPERTENSION	0.14% 1/721 • Number of events 1
Vascular disorders PHLEBITIS	0.14% 1/721 • Number of events 1
Vascular disorders THROMBOSIS	0.28% 2/721 • Number of events 2
Vascular disorders VENOUS THROMBOSIS LIMB	0.14% 1/721 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and the sponsor's representative will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
Publication restrictions are in place

Restriction type: OTHER