Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 17 for:    "Bone Disease" | "Sulfasalazine"
Previous Study | Return to List | Next Study

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00247962
Recruitment Status : Completed
First Posted : November 2, 2005
Results First Posted : November 8, 2012
Last Update Posted : November 8, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ankylosing Spondylitis
Interventions Drug: etanercept
Drug: sulphasalazine (SSZ)
Enrollment 566
Recruitment Details Subjects were recruited in multiple countries from December 2005 to September 2007.
Pre-assignment Details Subjects were screened up to 4 weeks in a 2:1 randomization ratio.
Arm/Group Title Etanercept Sulphasalazine
Hide Arm/Group Description etanercept 50 mg once weekly Sulphasalazine (SSZ) titration up to 3 g daily
Period Title: Overall Study
Started 379 187
Completed 353 168
Not Completed 26 19
Reason Not Completed
Adverse Event             15             12
Lost to Follow-up             3             1
Physician Decision             0             1
Protocol Violation             1             1
Withdrawal by Subject             3             2
Lack of Efficacy             4             2
Arm/Group Title Etanercept Sulphasalazine Total
Hide Arm/Group Description etanercept 50 mg once weekly Sulphasalazine (SSZ) titration up to 3 g daily Total of all reporting groups
Overall Number of Baseline Participants 379 187 566
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 379 participants 187 participants 566 participants
40.69  (11.69) 40.90  (12.23) 40.76  (11.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 379 participants 187 participants 566 participants
Female
100
  26.4%
47
  25.1%
147
  26.0%
Male
279
  73.6%
140
  74.9%
419
  74.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 379 participants 187 participants 566 participants
Qatar 7 3 10
Switzerland 2 1 3
Finland 11 3 14
Spain 12 7 19
Ireland 1 0 1
Austria 3 1 4
Italy 19 8 27
United Kingdom 38 19 57
France 4 1 5
Czech Republic 36 18 54
Hungary 27 15 42
Poland 30 15 45
Australia 5 2 7
Denmark 13 6 19
Netherlands 7 4 11
Germany 62 31 93
China 17 9 26
Sweden 4 2 6
Greece 4 3 7
Serbia 54 27 81
Mexico 11 6 17
Colombia 8 4 12
Portugal 4 2 6
1.Primary Outcome
Title Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)
Hide Description ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement from baseline and an improvement ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline efficacy evaluation. Last observation carried forward approach (LOCF) used for missing data imputations.
Arm/Group Title Etanercept Sulphasalazine
Hide Arm/Group Description:
etanercept 50 mg once weekly
Sulphasalazine (SSZ) titration up to 3 g daily
Overall Number of Participants Analyzed 378 187
Measure Type: Number
Unit of Measure: participants
287 99
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Sulphasalazine
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 Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 22.99
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline
Hide Description ASQoL is a questionnaire to assess disease specific quality of life. It consists of 18 statements that are relevant to the physical and mental conditions for a patient with Ankylosing Spondylitis (AS). Each statement is answered by the patients as a “Yes” (scored as 1) or “No” (scored as 0). All item scores are summed to give a total score. Scores can range from 0 (good QoL) to 18 (poor QoL).
Time Frame Baseline and 16 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was limited to subjects whose native language was English, Hungarian and Dutch.
Arm/Group Title Etanercept Sulphasalazine
Hide Arm/Group Description:
etanercept 50 mg once weekly
Sulphasalazine (SSZ) titration up to 3 g daily
Overall Number of Participants Analyzed 76 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 11.03  (4.60) 11.32  (4.75)
Week 16 6.21  (5.31) 9.06  (5.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept, Sulphasalazine
Comments baseline
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.719
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Etanercept, Sulphasalazine
Comments week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Etanercept Sulphasalazine
Hide Arm/Group Description etanercept 50 mg once weekly Sulphasalazine (SSZ) titration up to 3 g daily
All-Cause Mortality
Etanercept Sulphasalazine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept Sulphasalazine
Affected / at Risk (%) Affected / at Risk (%)
Total   7   4 
Cardiac disorders     
Supraventricular Tachycardia *  1/379 (0.26%)  0/187 (0.00%) 
Gastrointestinal disorders     
Colitis *  1/379 (0.26%)  0/187 (0.00%) 
Gastritis *  0/379 (0.00%)  1/187 (0.53%) 
General disorders     
Abdominal Pain *  0/379 (0.00%)  1/187 (0.53%) 
Accidental Injury *  0/379 (0.00%)  1/187 (0.53%) 
Musculoskeletal and connective tissue disorders     
Arthritis *  1/379 (0.26%)  0/187 (0.00%) 
Nervous system disorders     
Dizziness *  0/379 (0.00%)  1/187 (0.53%) 
Hypesthesia *  1/379 (0.26%)  0/187 (0.00%) 
Neuralgia *  1/379 (0.26%)  0/187 (0.00%) 
Paresis *  1/379 (0.26%)  0/187 (0.00%) 
Psychosis *  0/379 (0.00%)  1/187 (0.53%) 
Ptosis *  1/379 (0.26%)  0/187 (0.00%) 
Vertigo *  1/379 (0.26%)  0/187 (0.00%) 
Vascular disorders     
Migraine *  1/379 (0.26%)  0/187 (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%
Etanercept Sulphasalazine
Affected / at Risk (%) Affected / at Risk (%)
Total   213   100 
Eye disorders     
Special Senses *  25/379 (6.60%)  13/187 (6.95%) 
Gastrointestinal disorders     
Nausea *  25/379 (6.60%)  18/187 (9.63%) 
General disorders     
Headache *  29/379 (7.65%)  21/187 (11.23%) 
Injection Site Reaction *  41/379 (10.82%)  3/187 (1.60%) 
Metabolism and nutrition disorders     
Metabolic and Nutritional *  24/379 (6.33%)  5/187 (2.67%) 
Nervous system disorders     
Nervous *  24/379 (6.33%)  19/187 (10.16%) 
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection *  31/379 (8.18%)  17/187 (9.09%) 
Skin and subcutaneous tissue disorders     
Skin and appendages *  39/379 (10.29%)  14/187 (7.49%) 
Vascular disorders     
Cardiovascular *  23/379 (6.07%)  10/187 (5.35%) 
*
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
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00247962     History of Changes
Other Study ID Numbers: 0881A3-402
First Submitted: October 31, 2005
First Posted: November 2, 2005
Results First Submitted: January 30, 2009
Results First Posted: November 8, 2012
Last Update Posted: November 8, 2012