<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02201043</url>
  </required_header>
  <id_info>
    <org_study_id>SLDA-201</org_study_id>
    <nct_id>NCT02201043</nct_id>
  </id_info>
  <brief_title>Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Study of Thalidomide in the Treatment of Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pharmaceuticals Holding Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Pharmaceuticals Holding Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the&#xD;
           treatment of active ankylosing spondylitis.&#xD;
&#xD;
        2. To explore dose-effect relationships of taking thalidomide tablets once daily in the&#xD;
           treatment of active ankylosing spondylitis, as well as selecting the appropriate dose&#xD;
           for the further larger scale clinical trials.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)</measure>
    <time_frame>week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of ASDAS score</measure>
    <time_frame>week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of ASDAS score</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in back pain using a Visual Anolog Scale(VAS)</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morning stiffness</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Peripheral swollen joints</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Peripheral joint tenderness</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chest expansion</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ESR</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Schober test</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scoliosis</measure>
    <time_frame>week 24</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Thalidomide 150mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thalidomide 100mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo po.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thalidomide 150mg</intervention_name>
    <arm_group_label>Thalidomide 150mg</arm_group_label>
    <other_name>Thalomid</other_name>
    <other_name>Fan Ying Ting</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thalidomide 100mg</intervention_name>
    <arm_group_label>Thalidomide 100mg</arm_group_label>
    <other_name>Thalomid</other_name>
    <other_name>Fan Ying Ting</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (1) Active Ankylosing Spondylitis, Age 18-65, both outpatient or inpatient, both&#xD;
             gender;&#xD;
&#xD;
          -  (2) AS patients after traditional therapy (Using NSAIDs in a stable dose for 1 month,&#xD;
             using oral corticosteroids, using NSAIDs for 3 months) still in active stage;&#xD;
&#xD;
          -  (3) Pregnancy test must be negative in the female subjects of childbearing age or wife&#xD;
             of the male subjects;&#xD;
&#xD;
          -  (4)Female subjects with fertility during the trial (of 32 weeks) agreed to take a&#xD;
             double medically accepted and reliable contraceptive measures, which includes a drug&#xD;
             and a non-drug contraceptive measures; if the spouses of male subjects have fertility,&#xD;
             agreed to use latex condoms for contraception;&#xD;
&#xD;
          -  (5)Willing to have the treatment according to the plan as well as do the follow-up&#xD;
             exam on time;&#xD;
&#xD;
          -  (6)Understand and voluntarily signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Suffering from or have suffered from rheumatoid arthritis, disc prolapse, septic&#xD;
             arthritis, diffuse idiopathic skeletal hyperostosis syndrome, iliac dense osteitis,&#xD;
             psoriatic arthritis, bowel disease arthritis, Reiter syndrome;&#xD;
&#xD;
          -  (2) Severe AS, spine completely stiff (X-ray class IV) or the disease has been shown&#xD;
             to have a shorter survival period;&#xD;
&#xD;
          -  (3) Previously had total hip arthroplasty surgical treatment or appropriate to have&#xD;
             the surgery;&#xD;
&#xD;
          -  (4) Previously received anti-TNF therapy;&#xD;
&#xD;
          -  (5) Used leflunomide within 3 months before screening;&#xD;
&#xD;
          -  (6) Severe or persistent infection requires antimicrobial therapy;&#xD;
&#xD;
          -  (7) Hepatitis B surface antigen or hepatitis C antibody test positive;&#xD;
&#xD;
          -  (8) HIV positive or have acquired immunodeficiency syndrome (AIDS) history;&#xD;
&#xD;
          -  (9) Malignancy, lymphoproliferative disease history;&#xD;
&#xD;
          -  (10) Severe diabetes;&#xD;
&#xD;
          -  (11) Resting hypotension (BP&lt;90/50 mmHg) or hypertension (BP&gt;170/100 mmHg), and&#xD;
             orthostatic hypotension and clinically significant ECG abnormalities;&#xD;
&#xD;
          -  (12) Over the past six months had a stroke, heart attack or other serious&#xD;
             cardiovascular disease (including heart failure, unstable angina or life-threatening&#xD;
             arrhythmias and coronary artery bypass graft surgery);&#xD;
&#xD;
          -  (13) WBC or neutrophils below the lower limit of normal;&#xD;
&#xD;
          -  (14) Liver dysfunction, AST or ALT l&gt; 2 times the upper limit of normal;&#xD;
&#xD;
          -  (15) Renal dysfunction, Cr&gt;2 times the upper limit of normal;&#xD;
&#xD;
          -  (16) Female subjects or spouses of male subjects have positive pregnancy test or be in&#xD;
             the sickling period or intend to fertility or unwilling to take effective&#xD;
             contraception;&#xD;
&#xD;
          -  (17) With clinical symptoms of serious drug abuse or alcohol abuse or mental illness&#xD;
             history;&#xD;
&#xD;
          -  (18) Participated in any clinical trials of drugs within 3 months before screening;&#xD;
&#xD;
          -  (19) Workers engaged in dangerous (eg drivers, machine operator, high-altitude&#xD;
             operations, etc.);&#xD;
&#xD;
          -  (20) A history of deep venous thrombosis or pulmonary embolism;&#xD;
&#xD;
          -  (21) Be allergic to Test drug ingredients (including excipients);&#xD;
&#xD;
          -  (22) Other reasons for not be enrolled.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Bengbu Medical College</name>
      <address>
        <city>Bengbu</city>
        <state>Anhui</state>
        <zip>233004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The General Hospital of People's Liberation Army</name>
      <address>
        <city>BeiJing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Guanghua Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>XiAn</city>
        <state>Shanxi</state>
        <zip>710032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sichuan Provincial People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Xinjiang Uygur Autonomous Region people's Hospital</name>
      <address>
        <city>Wulumuqi</city>
        <state>Xinjiang</state>
        <zip>830001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 17, 2015</last_update_submitted>
  <last_update_submitted_qc>November 17, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ankylosing spondylitis</keyword>
  <keyword>thalidomide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
    <mesh_term>Tolnaftate</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02201043
org study id: SLDA-201
nct id: NCT02201043
lead sponsor: 
has dmc: No
1. Evaluate the efficacy and safety of taking thalidomide tablets once daily in the
           treatment of active ankylosing spondylitis.

        2. To explore dose-effect relationships of taking thalidomide tablets once daily in the
           treatment of active ankylosing spondylitis, as well as selecting the appropriate dose
           for the further larger scale clinical trials.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Subjects Achieving Assessment in Ankylosing Spondylitis 20 (ASAS 20)
time frame: week 12
measure: Change of ASDAS score
time frame: week 12
measure: Change of ASDAS score
time frame: week 24
measure: Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
time frame: week 24
measure: Mean change from baseline in Bath Ankylosing Spondylitis Function Index(BASFI)
time frame: week 24
measure: Mean change from baseline in Nocturnal Pain using a Visual Analog Scale(VAS)
time frame: week 24
measure: Mean change from baseline in back pain using a Visual Anolog Scale(VAS)
time frame: week 24
measure: Morning stiffness
time frame: week 24
measure: Number of Peripheral swollen joints
time frame: week 24
measure: Number of Peripheral joint tenderness
time frame: week 24
measure: Chest expansion
time frame: week 24
measure: ESR
time frame: week 24
measure: CRP
time frame: week 24
measure: Schober test
time frame: week 24
measure: Scoliosis
time frame: week 24
arm group label: Thalidomide 150mg
arm group type: Active Comparator
description: Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks;100mg/qd.po.2weeks; 150mg/qd.po.to the end
arm group label: Thalidomide 100mg
arm group type: Active Comparator
description: Thalidomide 25mg/qd.po.2weeks; 50mg/qd.po.2weeks; 100mg/qd.po.to the end
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo po.
intervention type: Drug
intervention name: Thalidomide 150mg
arm group label: Thalidomide 150mg
other name: Thalomid
other name: Fan Ying Ting
intervention type: Drug
intervention name: Thalidomide 100mg
arm group label: Thalidomide 100mg
other name: Thalomid
other name: Fan Ying Ting
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
mesh term: Thalidomide
mesh term: Tolnaftate