Clinical Trials List
2016-09-30 - 2019-12-31
Phase II
Terminated7
ICD-10L40.53
Psoriatic spondylitis
ICD-10L40
Psoriasis
ICD-9696.0
Psoriatic arthropathy
A randomised, double-blind, placebo-controlled, proof-of-concept, dose-ranging study of BI 655066 in patients with active psoriatic arthritis
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Trial Applicant
Boehringer Ingelheim
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 洪偉哲 風濕免疫科
- Po-Hao Huang 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- Wei-Sheng Chen Division of Rheumatology
- Chang-Youh Tsai Division of Rheumatology
The Actual Total Number of Participants Enrolled
2 Completed
Audit
CRO
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Wen Chan Tsai 未分科
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Completed
Audit
None
Co-Principal Investigator
- 吳正欽 風濕免疫科
- 歐燦騰 風濕免疫科
- Jeng-Hsien Yen 風濕免疫科
- Sung Wan-Yu 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
2. Have PsA symptoms for ≥ 6 months prior to screening, as assessed by the investigator
3. Have PsA on the basis of the Classification Criteria for Psoriatic Arthritis (CASPAR) with peripheral symptoms at screening visit, as assessed by the investigator
4. Have ≥ 5 tender joints and ≥ 5 swollen joints at screening and randomisation visits, as assessed by the investigator
5. At least one PsO lesion or a documented personal history of PsO at screening, as assessed by the investigator
6. If patients receive concurrent PsA treatments, these need to be on stable doses as below:
- For subjects receiving MTX: subject has received treatment for ≥ 3 months,with stable dose and stable route of administration (not to exceed 25 mg MTX per week) for ≥ 4 weeks prior to randomisation to Week 24; subjects on MTX should be taking folic acid supplementation according to local standard of care before randomisation and during the trial to minimize the likelihood of MTX associated toxicity
- For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for ≥ 2 weeks prior to randomisation to Week 24
- For subjects receiving non-steroidal anti-inflammatory drugs (NSAIDs) or
paracetamol/acetaminophen PRN: the subject must be on stable dose for ≥ 2
weeks prior to randomisation to Week 24
7. Active PsA that has been inadequately controlled by standard doses of NSAIDs administered for ≥ 4 weeks, or traditional DMARDs (including sulfasalazine) administered for ≥ 3 months, or TNFi agents, or subjects are intolerant to NSAIDs or DMARDs or TNFi agents, as assessed by the investigator
8. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation
9. Women of childbearing potential* must be ready and able to use highly effective methods of birth control per ICH M3(R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
*Women of childbearing potential are defined as:
- having experienced menarche and are
- not postmenopausal (12 months with no menses without an alternative medical cause) and are
- not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy or bilateral salpingectomy ).
Exclusion Criteria
2. Has received any therapeutic agent directly targeted to IL-12/23 (including ustekinumab), IL-23 or IL-17 (including secukinumab)
3. Prior use of more than two different TNFi agents
4. Use of the following treatments:
- TNFi agents (including, infliximab, adalimumab, certolizumab pegol or golimumab) within 12 weeks prior to randomisation
- Etanercept within 8 weeks prior to randomisation
- Leflunomide without cholestyramine wash-out within 8 weeks prior to randomisation
- Systemic non-biologic medications for PsA or PsO (including apremilast and leflunomide with cholestyramine wash-out) and photochemotherapy within 4 weeks prior to randomisation
- Intraarticular injections (including steroids) and intramuscular or intravenous corticosteroid treatment within 4 weeks prior to randomisation
- Topical PsO medications and phototherapy within 2 weeks prior to randomisation
- Low and high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) within 2 weeks prior to randomisation.
5. Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 (e.g. rituximab), investigational agents (e.g.CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
6. Participation in another trial with an investigational drug or device within 4 weeks (if the trial is for PsA treatment, within 12 weeks) or 5 half-lives (whichever is greater) prior to randomisation
7. Use of any restricted medication as specified in Table 4.2.2.1: 1 or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
8. Plans for administration of live vaccines during the study period or within 6 weeks prior to randomisation.
9. History of allergy/hypersensitivity to a systemically administered biologic agent or its excipients
10. Active systemic infections during the last 2 weeks (exception: common cold) prior to randomisation, as assessed by the investigator
11. Chronic or relevant acute infections including HIV (human immunodeficiency virus), viral hepatitis and (or) active tuberculosis. Patients with a positive QuantiFERON TB or PPD test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the patient has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then tuberculosis treatment may be deferred until completion of the trial according to clinical judgment of investigator and local country guidelines.
12. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix
13. Major surgery performed within 12 weeks prior to randomisation or planned within 32 weeks after randomisation (e.g. hip replacement, aneurysm removal, stomach ligation), as assessed by the investigator
14. Evidence of a current or previous disease, medical condition (including chronic alcohol or drug abuse) other than PsA and PsO, surgical procedure (i.e., organ transplant), medical examination finding (including vital signs and electrocardiogram (ECG)), or laboratory value at the screening visit outside the reference range that in the opinion of the investigator is clinically significant and would make the study participant unreliable to adhere to the
protocol or to complete the trial, compromise the safety of the patient, or compromise the quality of the data.
15. Total white blood count (WBC) < 3,000/μL, or platelets < 100,000/μL or neutrophils < 1,500/μL, or hemoglobin <8.5 g/dL at screening
16. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x
the upper limit of normal, or serum direct bilirubin ≥ 1.5 mg/dL at screening
17. Positive rheumatoid factor or anti-cyclic-citrullinated peptide (anti-CCP) antibodies at screening
18. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
19. Patients with cochlear implants, cardiac pacemakers, metallic foreign bodies in their eye or who have an aneurysm clip in their brain, and/or ferromagnetic surgical implants in the body or claustrophobia (MRI-substudy patients only)
20. Patients who are legally institutionalized
The Estimated Number of Participants
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Taiwan
20 participants
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Global
180 participants
