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Trial record 1 of 1 for:    NCT00195494
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Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00195494
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : September 5, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: Etanercept
Drug: Methotrexate
Drug: Placebo
Enrollment 542

Recruitment Details Participants were recruited worldwide from November 2004 to February 2006.
Pre-assignment Details Participants were randomly assigned equally to 1 of 4 blinded treatment groups: Group (G) 1a received the combination of etanercept (E) and methotrexate (M) in year Y1 and Y2. G1b received the combination of E and M in Y1 and E alone in Y2. G2a received M alone in Y1 and the combination of E and M in Y2. G2b received M alone in Y1 and Y2.
Arm/Group Title Year 1 E+M / Year 2 E+M Year 1 M / Year 2 E+M Year 1 E+M / Year 2 E Year 1 M / Year 2 M Year 1 M+Placebo Year 1 E+M
Hide Arm/Group Description

Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).

Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).

Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).

No reduction of MTX dose is permitted in year two.

Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Period Title: Year 1
Started 0 0 0 0 268 274
Completed 0 0 0 0 189 221
Not Completed 0 0 0 0 79 53
Reason Not Completed
Adverse Event             0             0             0             0             34             27
System Toxicity             0             0             0             0             0             1
Lack of Efficacy             0             0             0             0             24             9
Compliance             0             0             0             0             5             1
Lost to Follow-up             0             0             0             0             1             0
Missed >4 consecutive doses             0             0             0             0             3             2
Protocol deviation             0             0             0             0             2             3
Physician Decision             0             0             0             0             1             0
Withdrawal by Subject             0             0             0             0             8             9
Protocol Violation             0             0             0             0             1             1
Period Title: Year 2
Started 111 [1] 90 111 [1] 99 0 0
Completed 104 74 93 76 0 0
Not Completed 7 16 18 23 0 0
Reason Not Completed
Adverse Event             3             7             5             9             0             0
Lack of Efficacy             0             1             7             7             0             0
Compliance             1             0             0             2             0             0
Lost to Follow-up             0             0             1             1             0             0
Missed >4 consecutive doses             1             1             1             0             0             0
Protocol deviation             0             1             0             0             0             0
Physician Decision             1             1             0             0             0             0
Withdrawal by Subject             1             5             4             3             0             0
System toxicity             0             0             0             1             0             0
[1]
A patient with Year 1 termination had taken drug briefly during Year 2 and thus counted in the data.
Arm/Group Title Year 1 M+Placebo Year 1 E+M Total
Hide Arm/Group Description

Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Total of all reporting groups
Overall Number of Baseline Participants 268 274 542
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 268 participants 274 participants 542 participants
51.50
(20.00 to 84.00)
52.50
(18.00 to 82.00)
52.00
(18.00 to 84.00)
[1]
Measure Description: Year 1 Overall Number of Baseline Participants is 542
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 268 participants 274 participants 542 participants
Female
194
  72.4%
204
  74.5%
398
  73.4%
Male
74
  27.6%
70
  25.5%
144
  26.6%
[1]
Measure Description: Year 1 participants collected from Arms M and E+M equal the stated overall participant population of 542. 411 of those participants were then entered into Year 2 Arms E+M/E+M, M/M+E, E+M/E, M/M. This measure provides the gender population for Year 1 only in order to accurately reflect the overall baseline population of 542.
1.Primary Outcome
Title The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.
Hide Description Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.
Arm/Group Title Year 1 M Year 1 E+M
Hide Arm/Group Description:
Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
Overall Number of Participants Analyzed 263 265
Measure Type: Number
Unit of Measure: participants
73 132
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Year 1 M, Year 1 E+M
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 22.0
Estimation Comments E+M (49.8%) - M (27.8%) creates the risk difference estimated value.
2.Primary Outcome
Title Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.
Hide Description The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the modified intent to treat participants from year 1, treatment arms M and E+M.
Arm/Group Title Year 1 M Year 1 E+M
Hide Arm/Group Description:
Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
Overall Number of Participants Analyzed 230 246
Measure Type: Number
Unit of Measure: participants
135 196
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Year 1 M, Year 1 E+M
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 21.0
Estimation Comments E+M (79.7%) - M (58.7%) creates the risk difference estimated value.
3.Secondary Outcome
Title Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death
Hide Description Safety report for entire trial where participants reported a serious adverse event that led to death.
Time Frame 12 and 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis population is the modified intent to treat for year 1 (542 overall baseline participants) and year 2 (411 overall baseline participants).
Arm/Group Title Year 2 E+M / E+M Year 2 M / E+M Year 2 E+M / E Year 2 M / M Year 1 M+Placebo Year 1 E+M
Hide Arm/Group Description:

Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).

Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).

Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).

No reduction of MTX dose is permitted in year two.

Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Overall Number of Participants Analyzed 111 90 111 99 268 274
Measure Type: Number
Unit of Measure: participants
0 0 0 1 0 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Year 1 E+M / Year 2 E+M Year 1 M / Year 2 E+M Year 1 E+M / Year 2 E Year 1 M / Year 2 M Year 1 M+Placebo Year 1 E+M
Hide Arm/Group Description

Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).

Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two.

Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).

Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).

No reduction of MTX dose is permitted in year two.

Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).

MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8.

All-Cause Mortality
Year 1 E+M / Year 2 E+M Year 1 M / Year 2 E+M Year 1 E+M / Year 2 E Year 1 M / Year 2 M Year 1 M+Placebo Year 1 E+M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Year 1 E+M / Year 2 E+M Year 1 M / Year 2 E+M Year 1 E+M / Year 2 E Year 1 M / Year 2 M Year 1 M+Placebo Year 1 E+M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8   11   10   12   34   33 
Cardiac disorders             
Angina unstable *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Arrhythmia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Aterial fibrillation *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Myocardial infarction *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Pericarditis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Ventricular tachycardia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Aortic valve stenosis *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Atrio ventricular block *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Mitral valve incompetence *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Ear and labyrinth disorders             
Vertigo *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Eye disorders             
Photophobia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Gastrointestinal disorders             
Appendicitis perforated *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Gastritis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  1/274 (0.36%) 
General gastrointestinal disorder *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Gastrointestinal haemorrhage *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Mechanical ileus *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Vomiting *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Abdominal pain upper *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Inguinal hernia *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
General disorders             
Chest pain *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  1/274 (0.36%) 
General physical health deterioration *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Systemic inflammatory response system *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Hepatobiliary disorders             
Cholelithiasis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  2/274 (0.73%) 
Gallbladder disorder *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Infections and infestations             
Acute sinusitis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  1/268 (0.37%)  0/274 (0.00%) 
Bronchitis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Chronic sinusitis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Diverticulitis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Gastroenteritis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Herpes zoster *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Lung infection *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Lyme disease *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Nasopharyngitis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Pneumonia *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  1/99 (1.01%)  1/268 (0.37%)  1/274 (0.36%) 
Septic athritis staphylococcal *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Skin infection *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Streptococcal infection *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Bursitis infected staphylococcal *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Pneumonia streptococcal *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Tonsillitis *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Injury, poisoning and procedural complications             
Accidental overdose *  2/111 (1.80%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Joint injury *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Overdose *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Pelvic fracture *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Procedural pain *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Radius fracture *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Spinal fracture *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Concussion *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Device failure *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Fall *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Ligament injury *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Skull fractured base *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Investigations             
Blood alkaline phosphatase increased *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Hepatic enzyme increased *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Transaminases increased *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Metabolism and nutrition disorders             
Diabetes mellitus *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Hyponatraemia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Musculoskeletal and connective tissue disorders             
Arthritis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Haemarthrosis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Intervertebral disc disorder *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Intervetebral disc protrusion *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  2/274 (0.73%) 
Osteoarthritis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  2/268 (0.75%)  0/274 (0.00%) 
Rheumatoid arthritis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  5/268 (1.87%)  2/274 (0.73%) 
Arthropathy *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Spondylolisthesis acquired *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Basal cell carcinoma *  0/111 (0.00%)  1/90 (1.11%)  1/111 (0.90%)  1/99 (1.01%)  1/268 (0.37%)  0/274 (0.00%) 
Bowen's disease *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Breast cancer *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  3/268 (1.12%)  0/274 (0.00%) 
Chronic lymphocytic leukamia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Prostate cancer *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Tongue neoplasm *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Gastrointestinal carcinoma *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Lung cancer metastatic *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Malignant melanoma of sights other than skin *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Metastases to lung *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Pancreatic carcinoma *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Transitional cell carcinoma *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Nervous system disorders             
Cerebral haemorrhage *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Headache *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Paraesthesia *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Syncope *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Syncope vasovagal *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Cerebellar infarction *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Cerebral infarction *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Cerebrovascular accident *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Hydrocephalus *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Sciatica *  0/111 (0.00%)  1/90 (1.11%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Psychiatric disorders             
Anxiety *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Sleep disorder *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Confusional state *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Renal and urinary disorders *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Renal colic *  1/111 (0.90%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Renal and urinary disorders             
Renal failure *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Urinary retention *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Reproductive system and breast disorders             
Testicular torsion *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Vaginal prolapse *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Idiopathic pulmonary fibrosis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Interstitial lung disease *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  2/274 (0.73%) 
Pneumonitis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Pneumothorax *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Dyspnoea *  0/111 (0.00%)  1/90 (1.11%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Pulmonary embolism *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Skin and subcutaneous tissue disorders             
Hyperhidrosis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Surgical and medical procedures             
Hip arthroplasty *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  2/268 (0.75%)  0/274 (0.00%) 
Hospitalisation *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Cholecystectomy *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Haemorrhoid operation *  0/111 (0.00%)  0/90 (0.00%)  1/111 (0.90%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Vascular disorders             
Deep vein thrombosis *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Infarction *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  1/274 (0.36%) 
Ischaemia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  1/268 (0.37%)  0/274 (0.00%) 
Aneurysm *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Year 1 E+M / Year 2 E+M Year 1 M / Year 2 E+M Year 1 E+M / Year 2 E Year 1 M / Year 2 M Year 1 M+Placebo Year 1 E+M
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   91   71   89   79   241   246 
Blood and lymphatic system disorders             
Blood and lymphatic *  6/111 (5.41%)  2/90 (2.22%)  2/111 (1.80%)  4/99 (4.04%)  4/268 (1.49%)  20/274 (7.30%) 
Cardiac disorders             
Cardiac disorders *  0/111 (0.00%)  5/90 (5.56%)  3/111 (2.70%)  1/99 (1.01%)  14/268 (5.22%)  14/274 (5.11%) 
Ear and labyrinth disorders             
Ear and labyrinth *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  16/268 (5.97%)  11/274 (4.01%) 
Eye disorders             
Eye *  5/111 (4.50%)  4/90 (4.44%)  5/111 (4.50%)  7/99 (7.07%)  20/268 (7.46%)  28/274 (10.22%) 
Gastrointestinal disorders             
Abdominal pain upper *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  27/268 (10.07%)  23/274 (8.39%) 
Diarhhea *  4/111 (3.60%)  2/90 (2.22%)  6/111 (5.41%)  7/99 (7.07%)  20/268 (7.46%)  24/274 (8.76%) 
Nausea *  8/111 (7.21%)  8/90 (8.89%)  4/111 (3.60%)  8/99 (8.08%)  48/268 (17.91%)  53/274 (19.34%) 
Vomiting *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  18/268 (6.72%)  11/274 (4.01%) 
Dyspepsia *  1/111 (0.90%)  0/90 (0.00%)  3/111 (2.70%)  5/99 (5.05%)  0/268 (0.00%)  0/274 (0.00%) 
General disorders             
Administration site conditions *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  50/268 (18.66%)  67/274 (24.45%) 
Infections and Infestations *  47/111 (42.34%)  33/90 (36.67%)  49/111 (44.14%)  42/99 (42.42%)  0/268 (0.00%)  0/274 (0.00%) 
Gastroenteritis *  7/111 (6.31%)  1/90 (1.11%)  1/111 (0.90%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Lower respiratory tract infection *  2/111 (1.80%)  1/90 (1.11%)  4/111 (3.60%)  5/99 (5.05%)  0/268 (0.00%)  0/274 (0.00%) 
Rhinitis *  2/111 (1.80%)  2/90 (2.22%)  6/111 (5.41%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Infections and infestations             
Nasopharyngitis *  10/111 (9.01%)  10/90 (11.11%)  10/111 (9.01%)  13/99 (13.13%)  42/268 (15.67%)  44/274 (16.06%) 
Upper respiratory tract infections *  6/111 (5.41%)  8/90 (8.89%)  5/111 (4.50%)  9/99 (9.09%)  19/268 (7.09%)  18/274 (6.57%) 
Urinary tract infections *  0/111 (0.00%)  2/90 (2.22%)  6/111 (5.41%)  4/99 (4.04%)  10/268 (3.73%)  17/274 (6.20%) 
Injury, poisoning and procedural complications             
Post procedural nausea *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  23/268 (8.58%)  18/274 (6.57%) 
Injury, poisoning and procedural complications *  13/111 (11.71%)  11/90 (12.22%)  15/111 (13.51%)  9/99 (9.09%)  0/268 (0.00%)  0/274 (0.00%) 
Investigations             
Investigations *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  50/268 (18.66%)  49/274 (17.88%) 
Alanine aminotransferase increased *  5/111 (4.50%)  7/90 (7.78%)  2/111 (1.80%)  1/99 (1.01%)  0/268 (0.00%)  0/274 (0.00%) 
Musculoskeletal and connective tissue disorders             
Rheumatoid arthritis *  6/111 (5.41%)  6/90 (6.67%)  4/111 (3.60%)  15/99 (15.15%)  36/268 (13.43%)  13/274 (4.74%) 
Back pain *  2/111 (1.80%)  3/90 (3.33%)  4/111 (3.60%)  6/99 (6.06%)  0/268 (0.00%)  0/274 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Neoplasms benign *  0/111 (0.00%)  7/90 (7.78%)  2/111 (1.80%)  3/99 (3.03%)  0/268 (0.00%)  0/274 (0.00%) 
Nervous system disorders             
Headache *  8/111 (7.21%)  4/90 (4.44%)  6/111 (5.41%)  4/99 (4.04%)  20/268 (7.46%)  29/274 (10.58%) 
Psychiatric disorders             
Psychiatric *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  23/268 (8.58%)  28/274 (10.22%) 
Depression *  1/111 (0.90%)  5/90 (5.56%)  0/111 (0.00%)  0/99 (0.00%)  0/268 (0.00%)  0/274 (0.00%) 
Renal and urinary disorders             
Renal and urinary *  8/111 (7.21%)  5/90 (5.56%)  2/111 (1.80%)  5/99 (5.05%)  19/268 (7.09%)  21/274 (7.66%) 
Respiratory, thoracic and mediastinal disorders             
Cough *  7/111 (6.31%)  2/90 (2.22%)  8/111 (7.21%)  6/99 (6.06%)  26/268 (9.70%)  23/274 (8.39%) 
Skin and subcutaneous tissue disorders             
Alopecia *  0/111 (0.00%)  0/90 (0.00%)  0/111 (0.00%)  0/99 (0.00%)  8/268 (2.99%)  15/274 (5.47%) 
Rash *  4/111 (3.60%)  5/90 (5.56%)  3/111 (2.70%)  4/99 (4.04%)  14/268 (5.22%)  16/274 (5.84%) 
Vascular disorders             
Hypertension *  5/111 (4.50%)  0/90 (0.00%)  3/111 (2.70%)  6/99 (6.06%)  22/268 (8.21%)  17/274 (6.20%) 
*
Indicates events were collected by non-systematic assessment
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 PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00195494     History of Changes
Other Study ID Numbers: 0881A-101548
First Submitted: September 13, 2005
First Posted: September 19, 2005
Results First Submitted: March 31, 2009
Results First Posted: September 5, 2012
Last Update Posted: September 5, 2012