A study to evaluate the efficacy at week 52 of subcutaneouslyadministered secukinumab monotherapy compared withsubcutaneously administered adalimumab monotherapy inpatients with active psoriatic arthritis

Phase 3

• Conditions: Health Condition 1: null- Psoriatic Arthritis

• Registration Number: CTRI/2017/10/010015
• Lead Sponsor: ovartis Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1Informed consent must be obtained before any assessment is performed.

2. Male or non-pregnant, non-lactating female subjects at least 18 years of age.

3. Diagnosis of PsA as classified by CASPAR criteria and with symptoms

for at least 6 months and with active PsA at baseline defined as >=3 tender joints out of 78

and >=3 swollen joints out of 76 (dactylitis of a digit, counts as one joint each).

4. Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (CCP) antibodies negative at

screening.

5. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of >=2 cm diameter

or nail changes consistent with psoriasis or documented history of plaque psoriasis.

6. Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization

with inadequate control of symptoms or at least one dose if stopped due to intolerance to

NSAIDs.

7 Subjects who are regularly receiving NSAIDs as part of their PsA therapy are required to

be on a stable dose for at least 2 weeks before study randomization and should remain on a

stable dose up to Week 52.

8. Subjects receiving corticosteroids must be on a stable dose of <=10 mg/day prednisone or

equivalent for at least 2 weeks before randomization and should remain on a stable dose

up to Week 52.

9. Subjects must have previously been treated with a cDMARD, including but not limited to

MTX, with an inadequate response to therapy, or must have stopped treatment due to

safety/tolerability problems after at least one administration of the cDMARD.

Subjects who are receiving a cDMARD will be allowed to enter the study only after

cDMARD discontinuation and appropriate wash-out e.g. 4 weeks prior to randomization

visit except for leflunomide, which has to be discontinued for 8 weeks prior to

randomization unless a cholestyramine wash-out has been performed.

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No

additional exclusions may be applied by the investigator, in order to ensure that the study

population will be representative of all eligible subjects.

Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of

contraception or other forms of hormonal contraception that have comparable efficacy

(failure rate <1%), for example hormone vaginal ring or transdermal hormone

contraception or placement of an intrauterine device (IUD) or intrauterine system

(IUS). In case of use of oral contraception, women should have been stable on the

same pill for a minimum of 3 months before taking investigational drug.

1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female

after conception and until the termination of gestation, confirmed by a positive human

chorionic gonadotropin (hCG) laboratory test.

Women of childbearing potential, defined as all women physiologically capable of

becoming pregnant, unless they are using effective methods of contraception during

dosing of study treatment and minimum 16 weeks or longer if local label requires it after

the last dose (e.g. 20 weeks in EU). Effective contraception methods include:

Total abstinence (when this is in line with the preferred and usual lifestyle of the

subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation

methods) and withdrawal are not acceptable methods of contraception.

Female sterilization (have had surgical bilateral oophorectomy with or without

hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking

investigational drug. In case of oophorectomy alone, only when the reproductive

status of the woman has been confirmed by follow up hormone level assessment.

2. Female sterilization (have had surgical bilateral oophorectomy with or without

hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking

investigational drug. In case of oophorectomy alone, only when the reproductive

status of the woman has been confirmed by follow up hormone level assessment.

3. Male sterilization (at least 6 months prior to screening). For female subjects on the

study, the vasectomized male partner should be the sole partner for that subject.

Barrier methods of contraception: Condom or Occlusive cap (diaphragm or

cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/vaginal

suppository.

Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of

contraception or other forms of hormonal contraception that have comparable efficacy

(failure rate <1%), for example hormone vaginal ring or transdermal hormone

contraception or placement of an intrauterine device (IUD) or intrauterine system

(IUS). In case of use of oral contraception, women should have been stable on the

same pill for a minimum of 3 months before taking investigational drug.

Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing

infectious or malignant process obtained within 3 months prior to screening and evaluated

by a qualified physician.

4. Previo

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
American College of Rheumatology 20 (ACR20) responseTimepoint: 52 weeks