Phase 2
Completed N=71
Efficacy of Re-treatment With Cimzia® in Subject With Chronic Plaque Psoriasis
Source: ClinicalTrials.gov NCT00329303 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study — 1.25; 0.20 units on a scale
Summary
The primary objective is to assess differences in PASI scores between Week 12 of Study C87040 [NCT00245765] and Week 12 of re-treatment in this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Psoriasis Activity and Severity Index (PASI) Scores Between Week 12 of the First Treatment in Study C87040 [NCT00245765] and Week 12 of Re-treatment in This Study |
1.25; 0.20 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 |
67.6; 86.5 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI75) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study |
50.0; 75.7 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 |
76.5; 89.2 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study |
67.6; 89.2 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From First Treatment Baseline in Study C87040 |
35.3; 48.6 | — |
| SECONDARY Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 of Re-treatment Period From Re-treatment Baseline in This Study |
29.4; 40.5 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at First Treatment Baseline in Study C87040 |
20.90; 21.00 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 1 of First Treatment Period in Study C87040 |
18.60; 18.60 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 2 of First Treatment Period in Study C87040 |
14.00; 14.40 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 3 of First Treatment Period in Study C87040 |
8.65; 11.35 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 4 of First Treatment Period in Study C87040 |
6.55; 8.60 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 6 of First Treatment Period in Study C87040 |
4.60; 5.80 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 8 of First Treatment Period in Study C87040 |
3.55; 3.80 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 10 of First Treatment Period in Study C87040 |
2.10; 2.45 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 12 of First Treatment Period in Study C87040 |
1.60; 1.80 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Re-treatment Baseline in This Study |
14.40; 14.20 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 2 of Re-treatment Period in This Study |
10.00; 9.90 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 4 of Re-treatment Period in This Study |
6.30; 6.90 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 6 of Re-treatment Period in This Study |
3.65; 4.40 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 8 of Re-treatment Period in This Study |
3.70; 2.70 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 10 of Re-treatment Period in This Study |
2.70; 2.25 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Week 12 of Re-treatment Period in This Study |
2.80; 2.00 | — |
| SECONDARY Psoriasis Activity and Severity Index (PASI) Score at Last Re-treatment Visit in This Study |
3.35; 2.00 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 1 of First Treatment Period in C87040 |
12.70; 13.17 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of First Treatment Period in C87040 |
29.94; 31.90 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 3 of First Treatment Period in C87040 |
54.99; 50.92 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of First Treatment Period in C87040 |
62.53; 60.31 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of First Treatment Period in C87040 |
80.03; 72.41 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of First Treatment Period in C87040 |
82.80; 84.78 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of First Treatment Period in C87040 |
87.74; 89.94 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of First Treatment Period in C87040 |
92.45; 90.60 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Re-treatment Baseline in This Study |
33.48; 32.00 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 2 of Re-treatment Period in This Study |
58.41; 53.08 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 4 of Re-treatment Period in This Study |
71.01; 72.56 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 6 of Re-treatment Period in This Study |
80.86; 83.62 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 8 of Re-treatment Period in This Study |
82.00; 86.46 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 10 of Re-treatment Period in This Study |
87.13; 90.75 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Week 12 of Re-treatment Period in This Study |
84.11; 91.78 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From First Treatment Baseline in Study C87040 to Last Re-treatment Visit in This Study |
83.46; 87.94 | — |
| SECONDARY Percentage Change in Psoriasis Activity and Severity Index (PASI) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment in This Study |
78.75; 87.59 | — |
| SECONDARY Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040 |
1.60; 1.60 | — |
| SECONDARY Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study |
2.00; 1.80 | — |
| SECONDARY Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week First Treatment Period in Study C87040 |
11.00; 12.00 | — |
| SECONDARY Time to Reach Best Psoriasis Activity and Severity Index (PASI) Score During the 12 Week Re-treatment Period in This Study |
8.00; 9.86 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Re-treatment Baseline in This Study |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Week 2 of Re-treatment Period in This Study |
0; 0; 0; 0; 9; 8 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Week 4 of Re-treatment Period in This Study |
1; 0; 7; 8; 11; 11 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Week 6 of Re-treatment Period in This Study |
3; 4; 9; 8; 11; 15 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Week 8 of Re-treatment Period in This Study |
3; 5; 9; 14; 10; 11 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Week 10 of Re-treatment Period in This Study |
7; 5; 9; 15; 7; 11 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Week 12 of Re-treatment Period in This Study |
6; 10; 12; 11; 4; 11 | — |
| SECONDARY Psoriasis Global Assessment (PGA) Rating at Last Re-treatment Visit in This Study |
6; 10; 12; 13; 5; 12 | — |
| SECONDARY Percentage of Subjects Who Achieve a Psoriasis Global Assessment (PGA) Clear or Almost Clear Response at Week 12 of Re-treatment in This Study |
52.9; 56.8 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Re-treatment Baseline in This Study |
16.0; 15.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Week 2 of Re-treatment Period in This Study |
12.5; 14.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Week 4 of Re-treatment Period in This Study |
9.5; 10.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Week 6 of Re-treatment Period in This Study |
6.0; 7.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Week 8 of Re-treatment Period in This Study |
5.0; 5.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Week 10 of Re-treatment Period in This Study |
3.0; 4.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Week 12 of Re-treatment Period in This Study |
3.0; 3.0 | — |
| SECONDARY BSA (Body Surface Area) Affected by Psoriasis at Last Re-treatment Visit in This Study |
3.5; 3.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Re-treatment Baseline in This Study |
9.0; 7.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 2 of Re-treatment Period in This Study |
11.0; 10.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 4 of Re-treatment Period in This Study |
13.0; 12.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 6 of Re-treatment Period in This Study |
13.5; 19.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 8 of Re-treatment Period in This Study |
15.0; 18.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 10 of Re-treatment Period in This Study |
15.0; 20.5 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Week 12 of Re-treatment Period in This Study |
15.0; 20.5 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From First Treatment Baseline in C87040 to Last Re-treatment Visit in This Study |
15.0; 22.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 2 of Re-treatment Period in This Study |
2.5; 0.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 4 of Re-treatment Period in This Study |
4.0; 3.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 6 of Re-treatment Period in This Study |
7.0; 7.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 8 of Re-treatment Period in This Study |
10.0; 9.0 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 10 of Re-treatment Period in This Study |
12.5; 9.5 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Week 12 of Re-treatment Period in This Study |
10.5; 10.5 | — |
| SECONDARY Change in BSA (Body Surface Area) Score From Re-treatment Baseline in This Study to Last Re-treatment Visit in This Study |
10.0; 11.0 | — |
| SECONDARY Time to Withdrawal From the Treatment Due to Lack of Efficacy or Due to AE ('Worsening or Exacerbation of Psoriasis') During the 12 Week Re-treatment Period in This Study |
56.00; NA | — |
Eligibility Criteria
Inclusion Criteria
- Subject having responded to treatment at Week 12 in study C87040 and having relapsed during the follow-up period
- Female subjects either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practising an acceptable method of contraception.Subjects agreed to continue using adequate contraception during the study and for 12 weeks after the last dose of CDP870
Exclusion Criteria
- Subjects with erythrodermic, guttate, generalized pustular form of psoriasis
- Any recent serious or life-threatening infection or any current sign or symptom that may indicate an infection (e.g., fever, cough)
- Positive hepatitis B surface antigen test and /or hepatitis C antibody test results
- Positive human immunodeficiency virus (HIV) test result
- White blood cell counts less than 4000 per cubic millimeter or more than 20000 per cubic millimeter
- Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
- Systemic Lupus Erythematosus
- Participation in a clinical study within the past 3 months except Study C87040
- Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Data sourced from ClinicalTrials.gov (NCT00329303). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.