Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422AM1)(COMPLETED) - Study Results

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Condition:	Arthritis, Psoriatic
Interventions:	Drug: Infliximab + methotrexate (IFX + MTX) Drug: Methotrexate (MTX)

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
115 subjects (57 infliximab (IFX) + MTX and 58 MTX), but only 110 subjects (56 and 54) were considered intent to treat (ITT). Furthermore, 99 subjects (51 + 48) were in a treatment group at Week 16 for Primary Endpoint evaluation.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Infliximab + Methotrexate (IFX + MTX)	Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Methotrexate (MTX)	Oral methotrexate (MTX) 15 mg/week

Participant Flow: Overall Study

	Infliximab + Methotrexate (IFX + MTX)	Methotrexate (MTX)
STARTED	57^[1]	58^[2]
COMPLETED	47	47
NOT COMPLETED	10	11
Adverse Event	7	2
Lost to Follow-up	1	0
Withdrawal by Subject	0	4
Protocol Violation	2	5

[1]	Number of subjects randomized
[2]	Number of subjects randomized

Baseline Characteristics

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Reporting Groups

	Description
Infliximab + Methotrexate (IFX + MTX)	Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Methotrexate (MTX)	Oral methotrexate (MTX) 15 mg/week

Baseline Measures

	Infliximab + Methotrexate (IFX + MTX)	Methotrexate (MTX)	Total
Number of Participants [units: participants]	56	54	110
Age^[1] [units: years] Mean ( Full Range )	40.1 ( 20 to 65 )	42.3 ( 21 to 65 )	41.2 ( 20 to 65 )
Gender [units: participants]
Female	29	21	50
Male	27	33	60

[1]	ITT population

Outcome Measures

1. Primary:

Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16 [ between baseline and week 16 ]

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Measure Type	Primary
Measure Title	Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16
Measure Description	>=20% improvement in swollen and tender joint count AND >=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.
Time Frame	between baseline and week 16
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of subjects from Intent-to-Treat population in each arm at Week 16

Reporting Groups

	Description
Infliximab + Methotrexate (IFX + MTX)	Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
Methotrexate (MTX)	Oral methotrexate (MTX) 15 mg/week

Measured Values

	Infliximab + Methotrexate (IFX + MTX)	Methotrexate (MTX)
Number of Participants Analyzed [units: participants]	51	48
Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16 [units: participants]	44	32

Statistical Analysis 1 for Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16

Groups ^[1]	All groups
Method ^[2]	Chi-squared
P Value ^[3]	0.0210
Difference in percentages of respondents ^[4]	19.61
95% Confidence Interval	( 3.27 to 35.95 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Comparison of treatments (IFX + MTX versus MTX)
[4]	Other relevant estimation information:
	Difference in percentages of respondents is (percentage of respondents in IFX+MTX group minus percentage of respondents in MTX group)

Statistical Analysis 2 for Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16

Groups ^[1]	Infliximab + Methotrexate (IFX + MTX)
Proportion of Responders ^[2]	0.863

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant estimation information:
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Statistical Analysis 3 for Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16

Groups ^[1]	Methotrexate (MTX)
Proportion of Responders ^[2]	0.667

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant estimation information:
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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator must provide 30 days written notice to sponsor prior to submission for publication/presentation, so that sponsor can review the material(s). If the parties disagree concerning the appropriateness of the material for publication, the investigator must meet with sponsor prior to publication/presentation, in order to make good faith efforts to discuss and resolve any disagreements.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04422, EUDRACT #: 2005-002189-12
Study First Received:	August 18, 2006
Results First Received:	March 19, 2009
Last Updated:	May 21, 2009
ClinicalTrials.gov Identifier:	NCT00367237 History of Changes
Health Authority:	Russia: Pharmacological Committee, Ministry of Health; Estonia: The State Agency of Medicine; Lithuania: State Medicine Control Agency - Ministry of Health; Egypt: Ministry of Health and Population; Israel: Israeli Health Ministry Pharmaceutical Administration; Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Hungary: National Institute of Pharmacy; Romania: State Institute for Drug Control; Bulgaria: Ministry of Health; Croatia: Ministry of Health and Social Care; Slovenia: Agency for Medicinal Products - Ministry of Health; Turkey: Ministry of Health; South Africa: National Health Research Ethics Council; Qatar: Hamad Medical Corporation, Rheumatology Divison-Doha