An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Sponsor
Centocor, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00207714
Collaborator
Centocor BV (Industry)
172
3
27
Study Details
Study Description
Brief Summary
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis.
Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 20, 22, 28, 36, 44 for 48 weeks
Study Design
Study Type:
Interventional
Actual Enrollment
:
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Dose-ranging Trial of CNTO 148 Subcutaneous Injection Compared With Placebo in Subjects With Active Rheumatoid Arthritis Despite Treatment With Methotrexate
Study Start Date
:
Nov 1, 2003
Actual Primary Completion Date
:
Feb 1, 2005
Actual Study Completion Date
:
Feb 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Golimumab (CNTO 148) with Methotrexate (MTX)
|
Drug: Golimumab
Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
Drug: MTX
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
|
| Experimental: Infliximab with MTX
|
Drug: MTX
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
Drug: Infliximab
Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous
|
| Placebo Comparator: Placebo with MTX
|
Drug: MTX
Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
Drug: Placebo
Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [Week 16]
ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).
Secondary Outcome Measures
- Summary of ACR-N, Index of Improvement at Week 16 [Week 16]
The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
-
Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria
Exclusion Criteria:
-
Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
-
Received disease-modifying antirheumatic drugs ([DMARDs] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin [IL]-1 receptor antagonist [anakinra], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centocor, Inc.
- Centocor BV
Investigators
- Study Director: Centocor, Inc. Clinical Trial, Centocor, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00207714
Other Study ID Numbers:
- CR005263
- C0524T02
First Posted:
Sep 21, 2005
Last Update Posted:
Oct 18, 2012
Last Verified:
Oct 1, 2012
Keywords provided by ,
,
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | A total of 172 participants were randomly assigned to treatments at 33 sites: 16 in North America (13 in the US and 3 in Canada), 12 in Europe (3 in Belgium, 4 in the UK, 5 in Germany), and 5 in Australia. The study period extended from 01 Dec 2003 to 21 Feb 2006. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. | Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. | Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. | Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. | Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. |
| Period Title: Overall Study | |||||
| STARTED | 35 | 35 | 34 | 34 | 34 |
| COMPLETED | 21 | 28 | 24 | 26 | 29 |
| NOT COMPLETED | 14 | 7 | 10 | 8 | 5 |
Baseline Characteristics
| Arm/Group Title | Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. | Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. | Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. | Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. | Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. | Total of all reporting groups |
| Overall Participants | 35 | 35 | 34 | 34 | 34 | 172 |
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
53.8
(12.9)
|
56.1
(10.5)
|
50.4
(13.1)
|
56.3
(12.1)
|
54.1
(14.1)
|
54.2
(12.6)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
26
74.3%
|
30
85.7%
|
23
67.6%
|
26
76.5%
|
27
79.4%
|
132
76.7%
|
| Male |
9
25.7%
|
5
14.3%
|
11
32.4%
|
8
23.5%
|
7
20.6%
|
40
23.3%
|
Outcome Measures
| Title | Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 |
|---|---|
| Description | ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]). |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat (ITT). Participants considered non-responder if used any pre-specified prohibited medications or discontinued subcutaneous (SC) study agent due to lack of efficacy. Missing ACR components were imputed by Last Observation Carried Forward (LOCF) unless all ACR components are missing in which case considered non-responders. |
| Arm/Group Title | Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Combined: Groups II, III, IV & V |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. | Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. | Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. | Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. | Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. | Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks). |
| Measure Participants | 35 | 35 | 34 | 34 | 34 | 137 |
| Number [Participants] |
13
37.1%
|
21
60%
|
17
50%
|
19
55.9%
|
27
79.4%
|
84
48.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Combined: Groups II, III, IV & V |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Week 16 between combined golimumab groups and Placebo +MTX group. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25 % response in Placebo +MTX. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | A positive test is concluded if there is a significant difference between combined golimumab and placebo groups and at least one of the pair-wise comparisons at 0.05 level. | |
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group II: Golimumab 50 mg Every 4 Weeks |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 16 between golimumab 50 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.056 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group III: Golimumab 50 mg Every 2 or 4 Weeks |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 50 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.281 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group IV: Golibumab 100 mg Every 4 Weeks |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 4 weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.119 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group V: Golimumab 100 mg Every 2 or 4 Weeks |
|---|---|---|
| Comments | Null hypothesis: No difference in ACR 20 response at Wk 16 between Golimumab 100 mg every 2 or 4 Weeks and Placebo + MTX. Sample of 35 participants per treatment groups (140 in combined golimumab group and 35 in Placebo +MTX group) provides greater than 90% power assuming 60% golimumab response and 25% response in placebo. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | ||
| Title | Summary of ACR-N, Index of Improvement at Week 16 |
|---|---|
| Description | The ACR-N index of improvement is the minimum of the following: 1) the percent decrease from baseline in tender joint counts; 2) the percent decrease from baseline in swollen joint counts; 3) the median percent decrease from baseline for the following: a. Patient's assessment of pain as measured on a 10 cm visual assessment scale (0-10, 10 worst pain) Patient's global assessment of disease activity (VAS 0-10); c. Physician's global assessment of disease activity (VAS 0-10) d. Physical function as measured by the Health Assessment Questionnaire; e. C-Reactive Protein measurement. |
| Time Frame | Week 16 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat (ITT) and missing ACR components were imputed by LOCF unless all ACR components are missing in which case considered non-responders. The joint evaluability rules were also applied. |
| Arm/Group Title | Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | Combined: Groups II, III, IV & V |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study. | Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. | Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. | Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. | Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. | Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks). |
| Measure Participants | 35 | 35 | 34 | 34 | 34 | 137 |
| Median (Inter-Quartile Range) [Scores on scale] |
0.0
|
37.4
|
19.4
|
22.3
|
35.6
|
33.3
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Combined: Groups II, III, IV & V |
|---|---|---|
| Comments | No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and combined golimumab groups. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group II: Golimumab 50 mg Every 4 Weeks |
|---|---|---|
| Comments | No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 4 weeks | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group III: Golimumab 50 mg Every 2 or 4 Weeks |
|---|---|---|
| Comments | No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX and Golimumab 50 mg every 2 or 4 Weeks | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.095 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group IV: Golibumab 100 mg Every 4 Weeks |
|---|---|---|
| Comments | No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golibumab 100 mg every 4 weeks | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.010 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ANOVA on van der Waerden normal scores | |
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Group I: Placebo Crossover to Infliximab, Group V: Golimumab 100 mg Every 2 or 4 Weeks |
|---|---|---|
| Comments | No difference in ACRn scores measured as percentage of improvement from baseline at Week 16 between Placebo + MTX Golimumab 100 mg every 2 or 4 Weeks | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | ANOVA on van der Waerden normal scores. | |
| Comments | ||
Adverse Events
| Time Frame | Baseline to Week 52 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Twelve participants received an incorrect study agent or incorrect dose of Golimumab (CNTO 148) at least once through Week 16. For analyses performed by actual treatment received, 10 subjects were counted in treatment groups (based on total dose received) that differed from the treatment groups to which they had been randomly assigned. | |||||||||
| Arm/Group Title | Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | |||||
| Arm/Group Description | Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study. | Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks. | Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks. | Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks. | Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks. | |||||
All Cause Mortality |
||||||||||
| Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/34 (5.9%) | 7/37 (18.9%) | 5/32 (15.6%) | 5/33 (15.2%) | 5/35 (14.3%) | |||||
| Cardiac disorders | ||||||||||
| Angina unstable | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Cardiac failure congestive | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Cardiac tamponade | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Coronary artery stenosis | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Inguinal hernia | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Enterocolitis | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| General disorders | ||||||||||
| Chest pain | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 1/33 (3%) | 0/35 (0%) | |||||
| Infections and infestations | ||||||||||
| Bronchopneumonia | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Pneumonia | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Pneumonia legionella | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 1/33 (3%) | 0/35 (0%) | |||||
| Septic shock | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Sinusitis | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Listeria sepsis | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Lower respiratory tract infection | 1/34 (2.9%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Femur fracture | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Fractured coccyx | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Medical device complication | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hyperglycaemia | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Rheumatoid arthritis | 2/34 (5.9%) | 1/37 (2.7%) | 1/32 (3.1%) | 1/33 (3%) | 0/35 (0%) | |||||
| Back pain | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Fracture delayed union | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Intervertebral disc protrusion | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Basal cell carcinoma | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 1/33 (3%) | 0/35 (0%) | |||||
| Lung adenocarcinoma | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Squamous cell carcinoma | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Nervous system disorders | ||||||||||
| Nerve root compression | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Reproductive system and breast disorders | ||||||||||
| Benign prostatic hyperplasia | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Chronic obstructive airways disease exacerbated | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 1/33 (3%) | 0/35 (0%) | |||||
| Vascular disorders | ||||||||||
| Thrombophlebitis superficial | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Group I: Placebo Crossover to Infliximab | Group II: Golimumab 50 mg Every 4 Weeks | Group III: Golimumab 50 mg Every 2 or 4 Weeks | Group IV: Golibumab 100 mg Every 4 Weeks | Group V: Golimumab 100 mg Every 2 or 4 Weeks | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 28/34 (82.4%) | 34/37 (91.9%) | 29/32 (90.6%) | 29/33 (87.9%) | 33/35 (94.3%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Eosinophilia | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 0/33 (0%) | 0/35 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| Vertigo | 1/34 (2.9%) | 0/37 (0%) | 2/32 (6.3%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Tinnitus | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Eye disorders | ||||||||||
| Dry eye | 1/34 (2.9%) | 0/37 (0%) | 0/32 (0%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Conjunctivitis | 1/34 (2.9%) | 2/37 (5.4%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 2/34 (5.9%) | 5/37 (13.5%) | 8/32 (25%) | 7/33 (21.2%) | 8/35 (22.9%) | |||||
| Diarrhoea | 4/34 (11.8%) | 5/37 (13.5%) | 3/32 (9.4%) | 3/33 (9.1%) | 6/35 (17.1%) | |||||
| Vomiting | 2/34 (5.9%) | 5/37 (13.5%) | 0/32 (0%) | 2/33 (6.1%) | 5/35 (14.3%) | |||||
| Abdominal pain upper | 4/34 (11.8%) | 2/37 (5.4%) | 2/32 (6.3%) | 3/33 (9.1%) | 1/35 (2.9%) | |||||
| Abdominal pain | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Constipation | 1/34 (2.9%) | 2/37 (5.4%) | 1/32 (3.1%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Dyspepsia | 0/34 (0%) | 4/37 (10.8%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Mouth ulceration | 0/34 (0%) | 2/37 (5.4%) | 0/32 (0%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Gingival pain | 0/34 (0%) | 2/37 (5.4%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Toothache | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 0/33 (0%) | 0/35 (0%) | |||||
| General disorders | ||||||||||
| Injection site erythema | 4/34 (11.8%) | 5/37 (13.5%) | 5/32 (15.6%) | 4/33 (12.1%) | 10/35 (28.6%) | |||||
| Fatigue | 0/34 (0%) | 2/37 (5.4%) | 4/32 (12.5%) | 2/33 (6.1%) | 3/35 (8.6%) | |||||
| Pyrexia | 1/34 (2.9%) | 3/37 (8.1%) | 1/32 (3.1%) | 4/33 (12.1%) | 2/35 (5.7%) | |||||
| Injection site pain | 0/34 (0%) | 1/37 (2.7%) | 2/32 (6.3%) | 3/33 (9.1%) | 2/35 (5.7%) | |||||
| Oedema peripheral | 0/34 (0%) | 3/37 (8.1%) | 3/32 (9.4%) | 1/33 (3%) | 1/35 (2.9%) | |||||
| Chest pain | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 1/33 (3%) | 3/35 (8.6%) | |||||
| Injection site pruritus | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 1/33 (3%) | 3/35 (8.6%) | |||||
| Chills | 2/34 (5.9%) | 0/37 (0%) | 1/32 (3.1%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Injection site induration | 0/34 (0%) | 1/37 (2.7%) | 1/32 (3.1%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Malaise | 0/34 (0%) | 2/37 (5.4%) | 0/32 (0%) | 1/33 (3%) | 1/35 (2.9%) | |||||
| Injection site haemorrhage | 1/34 (2.9%) | 0/37 (0%) | 2/32 (6.3%) | 1/33 (3%) | 0/35 (0%) | |||||
| Infections and infestations | ||||||||||
| Nasopharyngitis | 3/34 (8.8%) | 8/37 (21.6%) | 3/32 (9.4%) | 2/33 (6.1%) | 8/35 (22.9%) | |||||
| Upper respiratory tract infection | 7/34 (20.6%) | 6/37 (16.2%) | 6/32 (18.8%) | 5/33 (15.2%) | 4/35 (11.4%) | |||||
| Influenza | 0/34 (0%) | 4/37 (10.8%) | 2/32 (6.3%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Sinusitis | 2/34 (5.9%) | 3/37 (8.1%) | 3/32 (9.4%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Bronchitis | 1/34 (2.9%) | 3/37 (8.1%) | 0/32 (0%) | 0/33 (0%) | 5/35 (14.3%) | |||||
| Herpes simplex | 1/34 (2.9%) | 3/37 (8.1%) | 2/32 (6.3%) | 1/33 (3%) | 1/35 (2.9%) | |||||
| Urinary tract infection | 2/34 (5.9%) | 2/37 (5.4%) | 0/32 (0%) | 3/33 (9.1%) | 1/35 (2.9%) | |||||
| Gastroenteritis viral | 1/34 (2.9%) | 1/37 (2.7%) | 1/32 (3.1%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Lower respiratory tract infection | 3/34 (8.8%) | 1/37 (2.7%) | 0/32 (0%) | 3/33 (9.1%) | 1/35 (2.9%) | |||||
| Respiratory tract infection | 1/34 (2.9%) | 3/37 (8.1%) | 1/32 (3.1%) | 1/33 (3%) | 0/35 (0%) | |||||
| Viral infection | 0/34 (0%) | 2/37 (5.4%) | 1/32 (3.1%) | 1/33 (3%) | 1/35 (2.9%) | |||||
| Pharyngitis | 0/34 (0%) | 2/37 (5.4%) | 0/32 (0%) | 1/33 (3%) | 1/35 (2.9%) | |||||
| Rhinitis | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 3/35 (8.6%) | |||||
| Nail infection | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 1/33 (3%) | 0/35 (0%) | |||||
| Ear infection | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Fungal rash | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 0/33 (0%) | 0/35 (0%) | |||||
| Gingival infection | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 0/33 (0%) | 0/35 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Contusion | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 2/33 (6.1%) | 2/35 (5.7%) | |||||
| Thermal burn | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Excoriation | 1/34 (2.9%) | 1/37 (2.7%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Arthropod bite | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Investigations | ||||||||||
| Alanine aminotransferase increased | 0/34 (0%) | 1/37 (2.7%) | 4/32 (12.5%) | 3/33 (9.1%) | 1/35 (2.9%) | |||||
| Aspartate aminotransferase increased | 0/34 (0%) | 1/37 (2.7%) | 3/32 (9.4%) | 3/33 (9.1%) | 1/35 (2.9%) | |||||
| Blood cholesterol increased | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Blood pressure increased | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Liver function test abnormal | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Rheumatoid arthritis | 5/34 (14.7%) | 8/37 (21.6%) | 7/32 (21.9%) | 4/33 (12.1%) | 7/35 (20%) | |||||
| Arthralgia | 0/34 (0%) | 3/37 (8.1%) | 5/32 (15.6%) | 2/33 (6.1%) | 5/35 (14.3%) | |||||
| Back pain | 1/34 (2.9%) | 3/37 (8.1%) | 3/32 (9.4%) | 2/33 (6.1%) | 2/35 (5.7%) | |||||
| Muscle spasms | 1/34 (2.9%) | 3/37 (8.1%) | 2/32 (6.3%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Pain in extremity | 2/34 (5.9%) | 1/37 (2.7%) | 3/32 (9.4%) | 1/33 (3%) | 3/35 (8.6%) | |||||
| Osteoarthritis | 0/34 (0%) | 3/37 (8.1%) | 0/32 (0%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Joint swelling | 0/34 (0%) | 2/37 (5.4%) | 1/32 (3.1%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Neck pain | 0/34 (0%) | 1/37 (2.7%) | 2/32 (6.3%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Arthritis | 0/34 (0%) | 1/37 (2.7%) | 0/32 (0%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Bursitis | 0/34 (0%) | 2/37 (5.4%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Myalgia | 0/34 (0%) | 0/37 (0%) | 3/32 (9.4%) | 0/33 (0%) | 0/35 (0%) | |||||
| Shoulder pain | 0/34 (0%) | 0/37 (0%) | 1/32 (3.1%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Benign breast neoplasm | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 2/33 (6.1%) | 0/35 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 7/34 (20.6%) | 8/37 (21.6%) | 6/32 (18.8%) | 9/33 (27.3%) | 3/35 (8.6%) | |||||
| Dizziness | 6/34 (17.6%) | 1/37 (2.7%) | 3/32 (9.4%) | 4/33 (12.1%) | 3/35 (8.6%) | |||||
| Paraesthesia | 0/34 (0%) | 3/37 (8.1%) | 2/32 (6.3%) | 1/33 (3%) | 0/35 (0%) | |||||
| Hypoaesthesia | 0/34 (0%) | 1/37 (2.7%) | 1/32 (3.1%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Sciatica | 0/34 (0%) | 3/37 (8.1%) | 0/32 (0%) | 1/33 (3%) | 0/35 (0%) | |||||
| Balance disorder | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 0/34 (0%) | 0/37 (0%) | 2/32 (6.3%) | 0/33 (0%) | 0/35 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 1/34 (2.9%) | 3/37 (8.1%) | 5/32 (15.6%) | 4/33 (12.1%) | 4/35 (11.4%) | |||||
| Dyspnoea | 0/34 (0%) | 2/37 (5.4%) | 2/32 (6.3%) | 3/33 (9.1%) | 2/35 (5.7%) | |||||
| Pharyngolaryngeal pain | 2/34 (5.9%) | 2/37 (5.4%) | 3/32 (9.4%) | 2/33 (6.1%) | 1/35 (2.9%) | |||||
| Nasal congestion | 0/34 (0%) | 2/37 (5.4%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Rhinitis seasonal | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus | 3/34 (8.8%) | 2/37 (5.4%) | 0/32 (0%) | 1/33 (3%) | 3/35 (8.6%) | |||||
| Rash | 3/34 (8.8%) | 2/37 (5.4%) | 1/32 (3.1%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Dermatitis | 0/34 (0%) | 3/37 (8.1%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Ecchymosis | 0/34 (0%) | 1/37 (2.7%) | 2/32 (6.3%) | 1/33 (3%) | 0/35 (0%) | |||||
| Hyperhidrosis | 1/34 (2.9%) | 0/37 (0%) | 3/32 (9.4%) | 0/33 (0%) | 1/35 (2.9%) | |||||
| Rash pruritic | 0/34 (0%) | 2/37 (5.4%) | 1/32 (3.1%) | 0/33 (0%) | 0/35 (0%) | |||||
| Increased tendency to bruise | 0/34 (0%) | 0/37 (0%) | 0/32 (0%) | 0/33 (0%) | 2/35 (5.7%) | |||||
| Skin exfoliation | 0/34 (0%) | 2/37 (5.4%) | 0/32 (0%) | 0/33 (0%) | 0/35 (0%) | |||||
| Urticaria | 2/34 (5.9%) | 0/37 (0%) | 0/32 (0%) | 1/33 (3%) | 0/35 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 1/34 (2.9%) | 4/37 (10.8%) | 3/32 (9.4%) | 1/33 (3%) | 2/35 (5.7%) | |||||
| Hot flush | 2/34 (5.9%) | 1/37 (2.7%) | 2/32 (6.3%) | 1/33 (3%) | 0/35 (0%) | |||||
Limitations/Caveats
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <= 5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Generally, the only disclosure restriction on the Principal Investigator is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Director Clinical Research |
|---|---|
| Organization | Centocor Research & Development, Inc. |
| Phone | 1-800-457-6399 |
Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00207714
Other Study ID Numbers:
- CR005263
- C0524T02
First Posted:
Sep 21, 2005
Last Update Posted:
Oct 18, 2012
Last Verified:
Oct 1, 2012