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Real Life Dosing of Remicade for Rheumatoid Arthritis in Austria Monitored Over 9 Infusions (Study P03756)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00725621
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : August 4, 2011
Last Update Posted : September 3, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Biological: Infliximab
Enrollment 516
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in Summary of Product Characteristics (SPC) was taken into consideration.
Period Title: Overall Study
Started 516 [1]
Completed 245 [2]
Not Completed 271
Reason Not Completed
Adverse Event             25
Lack of Efficacy             46
Withdrawal by Subject             57
Physician Decision             19
Lost to Follow-up             52
Non-compliance             8
Continued treatment by other physician             6
Switched to other study             1
Switched to other drug             1
Prepared for elective surgery             1
Reason not specified             55
[1]
Started was defined as the number of participants who received at least one infusion of Remicade.
[2]
Completed was defined as the number of participants who received 9 consecutive Remicade infusions.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Baseline Participants 516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 516 participants
55.43  (13.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants
Female
398
  77.1%
Male
118
  22.9%
1.Primary Outcome
Title Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Hide Description The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time Frame Maximum of 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers) Remicade (Specialized Hospitals Only) Remicade (Extramural Infusion Centers Only)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 193 120 73
Mean (Standard Deviation)
Unit of Measure: Days
Infusion 3/4 (n=193, n=120, n=73) 56.48  (10.94) 56.32  (7.76) 56.75  (14.82)
Infusion 4/5 (n=193, n=120, n=73) 57.55  (10.81) 56.83  (10.66) 58.73  (11.03)
Infusion 5/6 (n=178, n=110, n=68) 56.80  (10.85) 56.60  (13.07) 57.13  (5.75)
Infusion 6/7 (n=163, n=99, n=64) 56.07  (8.57) 55.41  (8.56) 57.09  (8.56)
Infusion 7/8 (n=153, n=91, n=62) 57.33  (10.97) 56.43  (12.11) 58.65  (8.97)
Infusion 8/9 (n=143, n=83, n=60) 57.04  (11.07) 56.60  (12.49) 57.65  (8.80)
2.Primary Outcome
Title Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
Hide Description The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time Frame Maximum of 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers) Remicade (Specialized Hospitals Only) Remicade (Extramural Infusion Centers Only)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 193 120 73
Median (Full Range)
Unit of Measure: Days
Infusion 3/4 (n=193, n=120, n=73)
57.00
(25.00 to 135.00)
57.00
(29.00 to 85.00)
57.00
(25.00 to 135.00)
Infusion 4/5 (n=193, n=120, n=73)
57.00
(41.00 to 120.00)
57.00
(41.00 to 116.00)
57.00
(43.00 to 120.00)
Infusion 5/6 (n=178, n=110, n=68)
57.00
(30.00 to 140.00)
57.00
(30.00 to 140.00)
57.00
(42.00 to 71.00)
Infusion 6/7 (n=163, n=99, n-64)
57.00
(30.00 to 106.00)
57.00
(41.00 to 92.00)
57.00
(30.00 to 106.00)
Infusion 7/8 (n=153, n=91, n=62)
57.00
(13.00 to 112.00)
57.00
(13.00 to 97.00)
57.00
(44.00 to 112.00)
Infusion 8/9 (n=143, n=83, n=60)
57.00
(24.00 to 113.00)
57.00
(24.00 to 113.00)
57.00
(43.00 to 111.00)
3.Primary Outcome
Title Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Hide Description The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time Frame Maximum of 102 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers) Remicade (Specialized Hospitals Only) Remicade (Extramural Infusion Centers Only)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 193 120 73
Mean (Standard Deviation)
Unit of Measure: milligrams/kilograms (mg/kg)
Infusion 1 (n=193, n=120, n=73) 3.42  (0.59) 3.50  (0.59) 3.30  (0.56)
Infusion 2 (n=192, n=119, n=73) 3.43  (0.59) 3.51  (0.59) 3.31  (0.56)
Infusion 3 (n=193, n=120, n=73) 3.46  (0.62) 3.56  (0.65) 3.30  (0.54)
Infusion 4 (n=193, n=120, n=73) 3.50  (0.62) 3.59  (0.63) 3.36  (0.57)
Infusion 5 (n=193, n=120, n=73) 3.53  (0.67) 3.62  (0.71) 3.36  (0.58)
Infusion 6 (n=178, n=110, n=68) 3.56  (0.70) 3.70  (0.75) 3.34  (0.54)
Infusion 7 (n=163, n=99, n=64) 3.63  (0.74) 3.78  (0.82) 3.39  (0.53)
Infusion 8 (n=153, n=91, n=62) 3.60  (0.72) 3.75  (0.79) 3.37  (0.53)
Infusion 9 (n=143, n=83, n=60) 3.61  (0.72) 3.79  (0.78) 3.36  (0.54)
4.Primary Outcome
Title Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
Hide Description The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time Frame Maximum of 102 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who received Remicade induction therapy and subsequent maintenance therapy during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers) Remicade (Specialized Hospitals Only) Remicade (Extramural Infusion Centers Only)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 193 120 73
Median (Full Range)
Unit of Measure: mg/kg
Infusion 1 (n=193, n=120, n=73)
3.33
(2.25 to 6.15)
3.38
(2.45 to 5.97)
3.23
(2.25 to 6.15)
Infusion 2 (n=192, n=119, n=73)
3.33
(2.25 to 6.15)
3.39
(2.56 to 5.97)
3.23
(2.25 to 6.15)
Infusion 3 (n=193, n=120, n=73)
3.33
(2.22 to 5.97)
3.40
(2.22 to 5.88)
3.23
(2.41 to 5.97)
Infusion 4 (n=193, n=120, n=73)
3.41
(2.44 to 5.80)
3.49
(2.50 to 5.80)
3.33
(2.44 to 5.80)
Infusion 5 (n=193, n=120, n=73)
3.39
(2.08 to 5.71)
3.53
(2.08 to 5.48)
3.33
(2.35 to 5.71)
Infusion 6 (n=178, n=110, n=68)
3.41
(2.13 to 5.71)
3.61
(2.13 to 5.48)
3.33
(2.35 to 5.71)
Infusion 7 (n=163, n=99, n=64)
3.53
(2.13 to 5.71)
3.70
(2.13 to 5.66)
3.33
(2.56 to 5.71)
Infusion 8 (n=153, n=91, n=62)
3.53
(2.13 to 5.71)
3.70
(2.13 to 5.56)
3.33
(2.50 to 5.71)
Infusion 9 (n=143, n=83, n=60)
3.53
(2.38 to 5.71)
3.70
(2.43 to 5.56)
3.33
(2.38 to 5.71)
5.Primary Outcome
Title Mean Remicade Dose Per Participant
Hide Description [Not Specified]
Time Frame Maximum of 102 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who were exposed to Remicade during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 500
Mean (Standard Deviation)
Unit of Measure: mg/kg
3.56  (0.63)
6.Primary Outcome
Title Median Remicade Dose Per Participant
Hide Description [Not Specified]
Time Frame Maximum of 102 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who were exposed to Remicade during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 500
Median (Full Range)
Unit of Measure: mg/kg
3.49
(2.08 to 5.85)
7.Secondary Outcome
Title Disease Progression Specified by the Time Period Between Onset of Rheumatoid Arthritis (RA) and Onset of Remicade Therapy
Hide Description [Not Specified]
Time Frame 24 months maximum
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who were exposed to Remicade during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 511
Mean (Standard Deviation)
Unit of Measure: Years
8.02  (8.07)
8.Secondary Outcome
Title Number and Kind of Previous Therapies With Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Hide Description Some participants had more than one previous treatment with a DMARD.
Time Frame 24 months maximum
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants who were exposed to Remicade during the observational study.
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 516
Measure Type: Number
Unit of Measure: Participants
Methotrexate 470
Sulfasalazine 111
Leflunomide 138
9.Secondary Outcome
Title Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the Physical Component Summary Score (PCS)
Hide Description Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the Mental Component Summary Score (MCS). The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time Frame 24 months maximum
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants with available data.
Arm/Group Title Remicade (Specialized Hospitals Only) Remicade (Extramural Infusion Centers Only)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 194 121
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline (n=194, n=121) 31.25  (15.78) 31.59  (16.81)
Endpoint (after 9 infusions; n=125, n=13)) 58.96  (22.26) 42.46  (20.78)
10.Secondary Outcome
Title Impact of Remicade Location (Specialized Hospitals Versus Extramural Infusion Centers) on the MCS
Hide Description Participant's quality of life was measured by the short-form 36 (SF-36). The SF-36 is a survey with 36 questions. It is composed of the PCS & the MCS. The SF-36 consisted of eight scaled scores, which were the weighted sums of the questions in their section. Each scale was directly transformed into a 0 (lowest level of functioning) - 100 (highest level of functioning) scale on the assumption that each question carried equal weight. The impact of the maintenance therapy location (specialized hospitals versus extramural infusion centers) was also examined.
Time Frame 24 months maximum
Hide Outcome Measure Data
Hide Analysis Population Description
Remicade-naive participants with available data.
Arm/Group Title Remicade (Specialized Hospitals Only) Remicade (Extramural Infusion Centers Only)
Hide Arm/Group Description:
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized hospitals. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in extramural infusion centers. Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
Overall Number of Participants Analyzed 194 124
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline (n=194, n=124) 43.89  (17.98) 45.12  (18.70)
Endpoint (after 9 infusions; n=125, n=13) 67.10  (20.96) 46.18  (25.71)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Remicade (Specialized Hospitals & Extramural Infusion Centers)
Hide Arm/Group Description Remicade induction therapy consisted of 3 infusions (3 mg/kg) in weeks 0, 2, and 6 given in specialized centers (specialized hospitals and extramural infusion centers). Maintenance therapy consisted of a maximum of 6 infusions (3 mg/kg) given in doses and intervals at the discretion of physician. The observation period could not exceed 102 weeks per participant if the maximal therapy interval of 16 weeks as defined in SPC was taken into consideration.
All-Cause Mortality
Remicade (Specialized Hospitals & Extramural Infusion Centers)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Remicade (Specialized Hospitals & Extramural Infusion Centers)
Affected / at Risk (%) # Events
Total   21/516 (4.07%)    
Blood and lymphatic system disorders   
Hypochromic anaemia  1/516 (0.19%)  1
Cardiac disorders   
Angina pectoris  1/516 (0.19%)  1
Tachycardia  1/516 (0.19%)  1
Ear and labyrinth disorders   
Deafness  1/516 (0.19%)  2
Gastrointestinal disorders   
Stomatitis  1/516 (0.19%)  1
Multi-organ failure  1/516 (0.19%)  1
General disorders   
Infusion related reaction  1/516 (0.19%)  1
Infections and infestations   
Gastroenteritis  1/516 (0.19%)  1
Herpes zoster  1/516 (0.19%)  1
Pneumonia  2/516 (0.39%)  2
Injury, poisoning and procedural complications   
Forearm fracture  1/516 (0.19%)  1
Pelvic fracture  1/516 (0.19%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Salivary gland adenoma  1/516 (0.19%)  1
Nervous system disorders   
Cerebrovascular accident  1/516 (0.19%)  1
Syncope  1/516 (0.19%)  1
Surgical and medical procedures   
Hip arthroplasty  1/516 (0.19%)  1
Hospitalisation  2/516 (0.39%)  2
Knee operation  1/516 (0.19%)  1
Wrist surgery  1/516 (0.19%)  1
Vascular disorders   
Thrombosis  1/516 (0.19%)  1
1
Term from vocabulary, MedDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Remicade (Specialized Hospitals & Extramural Infusion Centers)
Affected / at Risk (%) # Events
Total   0/516 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725621    
Other Study ID Numbers: P03756
First Submitted: July 25, 2008
First Posted: July 30, 2008
Results First Submitted: July 8, 2011
Results First Posted: August 4, 2011
Last Update Posted: September 3, 2015